Gehaltsübersicht für Quality Control Manager in Schweiz

We are pleased to represent an esteemed client operating within the dynamic Pharma sector, located in the Zug region, Switzerland. Our client is actively seeking a dedicated and skilled professional to join their team as a Quality Control Specialist.This exciting opportunity will allow you to play a vital role in upholding the quality and safety standards of pharmaceutical products in a highly regulated and rewarding environment. If you are passionate about precision, accuracy, and contributing to the advancement of healthcare, we invite you to explore this career opportunity with our client.ResponsibilitiesConducting incoming goods, intermediate, final, and stability control of BG/E products, as well as starting materials, intermediate products, and end products. Analyzing test results and documenting them according to GxP guidelines.Creating and processing error messages, variances, changes, and out-of-specification results (OOS). Organizing and planning laboratory activities while maintaining laboratory daily activities. Assisting in training Quality Control team members and other employees in Standard Operating Procedures (SOPs) and test methods for which you are qualified. Your ProfileEducational Background: Hold a laboratory certification or possess a relevant university degree in natural sciences. A minimum of 1-3 years in quality control, medical laboratory diagnostics, or chemical testing. Demonstrate a strong affinity for precise and accurate work, along with a commitment to maintaining high quality standards, applying good documentation practices. Proficiency in German is essential, and knowledge of English is considered advantageous. Desirable Expertise: The ideal candidate will also bring valuable expertise, including experience in quality control within the medical diagnostics field, familiarity with quality guidelines and regulations in the pharmaceutical sector and previous exposure to SAP P1U would be a significant asset BenefitsIf you possess these qualifications and you are eager to make a meaningful impact in the Pharma sector, we encourage you to explore this exceptional career opportunity. Join our client’s team and contribute to the quality and safety of pharmaceutical products in a dynamic and rewarding environment. If you meet the must-have qualifications and possess some of the nice-to-have qualifications, we encourage you to apply for this exciting opportunity. ContactIn case of any doubt on this vacancy (ref.: JN -102023-501870), please contact Jezabel Diaz at +41582334539 or [email protected] UsAdecco is the market leader for staffing solutions in Switzerland and worldwide. Every day, our teams in our 50 locations throughout Switzerland ensure the best match between candidates and clients in various professional fields and industries. Adecco Switzerland is part of the Adecco Group, the world’s leading talent advisory and solutions company. We believe in making the future work for everyone, and every day enable more than 3.5 million careers. We skill, develop, and hire talent in 60 countries, enabling organisations to embrace the future of work. As a Fortune Global 500 company, we lead by example, creating shared value that fuels economies and builds better societies. Our culture of inclusivity, entrepreneurship and teamwork empowers our 30,000 employees. We are proud to have been consistently ranked one of the 'World's Best Workplaces' by Great Place to Work. The Adecco Group AG is headquartered in Zurich, Switzerland (ISIN: CH0012138605) and listed on the SIX Swiss Exchange (ADEN). The Group is powered by three global business units: Adecco, Talent Solutions and Modis.#boost

Quality Assurance Manager Im Bereich Quality Management, Regulatory & Medical Affairs in der Abteilung Quality Assurance suchen wir am Standort Burgdorf eine kundenorientierte und qualitätsbewusste Persönlichkeit als Quality Assurance Manager | 80 - 100% Ref-Nr. 6367 Arbeitsort: Solothurn, Burgdorf | Hybrid Helfen Sie uns, modernste Medizintechnik-Lösungen auf den Markt zu bringen, indem Sie dank Ihrer strukturierten Herangehensweise Prozesse optimieren und die Qualität sicherstellen. Ihre Hauptaufgaben Sicherstellen der Qualitätsanforderungen für die Produktion von terminal sterilisierte Medical Devices sowie die dazugehörende technische Dokumentation gemäss ISO13485, MDR, CFR Part 820, produktspezifische Standards, nationale Guidelines und Gesetze für den gesamten Product Lifecycle im Verantwortungsbereich Koordination und Bearbeitung von Change Control Projekten und Aufrechterhaltung der dazugehörenden Dokumentation sowie Koordination und Bearbeitung von CAPAs im Verantwortungsbereich Review und Freigabe der Dokumente im Lifecycle Prozess (DMR, DHR) Ansprechpartner für Stakeholder aus den Bereichen Produktion, Entwicklung, und der Qualitätsorganisation Support und Teilnahme bei Behörden-, Kunden und Lieferantenaudits und die Bearbeitung bei Auditfindings Verantwortlich für die Reinraumbetreuung, inklusive Reinraummonitoring und Reinraumschulung von internem und externem Personal Unterstützung bei Sterilisationsprojekten mit Strahlensterilisation, verantwortlich für das Dose Audit Organisation und Bewertung von Daten zur Produktverbesserung Ihr Profil Abgeschlossenes technisches oder naturwissenschaftliches Studium (HF, Uni, FH) Mehrjährige Erfahrung in einer vergleichbaren Rolle im Bereich Medizinprodukte, Pharma oder Gesundheitswesen. Erfahrungen mit mikrobiologischen Prüfungen und Unterhalt von Reinräumen von Vorteil Erfahrung mit Business Software (SAP, Office, Jira, DOORs) Versiert in einschlägigen Qualitätsmethoden (Statistische Methoden, FMEAs, Lean Six Sigma, risikobasierte Entscheidungsfindung etc.) Eigeninitiativ und dienstleistungsorientiert Sehr gute Kommunikationsfähigkeiten in Deutsch und Englisch Darum Ypsomed - die Behandlung von chronischen Erkrankungen möglich machen Die weltweit über 2000 Mitarbeitenden der Ypsomed Gruppe entwickeln und produzieren Injektions- und Infusionssysteme für die Selbstmedikation. Wir sind ein erfolgreiches, rasch wachsendes, familiengeführtes Unternehmen mit Hauptsitz in Burgdorf (CH) und weltweit verschiedenen Produktionsstandorten und Tochtergesellschaften. Mit unseren marktführenden Produkten und Lösungen ermöglichen wir Menschen auf der ganzen Welt die Selbstbehandlung. Trotz chronischen Erkrankungen wie Diabetes, Fettleibigkeit oder gewissen Arten von Krebs erhalten sie damit grösstmögliche Freiheit. Kontakt Alain Rusconi Human Resources Expert Recruiting +41 (0) 34 424 28 64 Ihr zukünftiger Arbeitsort Solothurn Solothurn Burgdorf

Was ist meine Funktion?Qualifizierung von technischen Anlagen und ComputersystemenLeitung der Qualifizierungs- und Validierungsstrategie Verantwortung für die Qualifizierungs- und Validierungsarbeiten Teilnahme an Audits und Inspektionen Erstellung und Prüfung der GMP-relevanten Dokumentation Aufbau und Weiterentwicklung des Quality Management Systems Was brauche ich, um erfolgreich zu sein?Studium Maschinenbau, Verfahrenstechnik, ElektrotechnikEinige Jahre Berufserfahrung als Quality Systems ManagerSehr gute Kenntnisse in der Validierung und Qualifizierung Fundierte Kenntnisse in ComputersystemvalidierungErfahrung im Aufbau, Betrieb und Unterhalt von datenbankbasierten und validierten Software-SystemenInternationale ReisebereitschaftWas sind meine Vorteile?Innovatives UnternehmenFlexible ArbeitszeitenWeiterbildungsmöglichkeiten5 Wochen UrlaubSprachenDeutsch: C1 - VerhandlungssicherEnglisch: C1 - VerhandlungssicherArbeitsortBaselVakanz-Nr25E-8BL

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. In this role you will share oversight of Quality Control (QC) activities related to Drug Product and Incoming Material to ensure compliance with internal policies, procedures, and regulatory requirements. This position will provide support for design, execution, troubleshooting and monitoring of QC process and testing activities pertaining to raw material (including sampling), stability, in-process, and bulk product. You will be responsible for cGMP compliance of the laboratory area and operations under your responsibility as well as for applying and ensuring staff complies with Environmental Health & Safety applicable procedures. This position reports to the Associate Director Quality Control Drug Product and Incoming Material. Key Responsibilities Manage team and ensures cGMP compliance of the laboratory area and operations under responsibility. Create a positive and collaborative team environment and ensure that Bristol Myers Squibb standards are met. Manages performance and provides technical guidance, coaching and support to team members. Assigns training requirements and monitors training status of assigned team members. Create team plans to ensure resources are properly allocated and utilized effectively. Ensures all equipment used for GMP testing is in a qualified state. Authors, reviews, and approves complex GMP documentation such as laboratory procedures, work practices, plans, protocols, and reports. Support and sustains Lean Lab initiatives such as 5S, deviation reduction, Right First Time, and inspection readiness. Actively participates in inspections by Health Authorities. Report metrics to monitor schedule progress and help identify risk areas. Supports budget definition and adherence to budget target. Support purchase requisitions and purchase orders are managed as appropriate to ensure business needs are met in timely manner. Oversee QC incoming material, stability, in-process and bulk product testing activities. Collaborate cross-functionally and interdepartmental to define testing priorities, assign work to team members, and monitor progress against schedule. Ensure timely completion of stability samples in compliant with company procedures. Review and approve documentation as required by laboratory procedures. Perform final approval and disposition of QC results. Provide technical support to QC team members. Ensure compendial compliance of excipients (USP, Ph. Eur., JP and JPE as applicable) and evaluates any non-compendial supplier test methods against in-house methods and specifications. Defines incoming testing requirements of Incoming Materials, including specifications. Oversee sampling plan and testing regimes for all Incoming Materials. Provides oversight of testing contracted to external laboratories. Represents QC in cross-functional teams supporting New Product Introductions, Qualification and Risk Assessments. Support Deviations, Investigations and Change Control Management Ensures Deviations, CAPAs and Change controls are handled appropriately and in a timely manner. Initiates and/or implement changes in controlled documents. Own or lead investigations in collaboration with internal and external functions, as required. Approve laboratory investigations, checklists, and deviations as SME/Area Manager. Work with impacted QC area functions to define appropriate and effective corrective and preventive actions (CAPAs). Ensure timely and compliant closure of QC deviations/investigations and CAPAs according to Bristol Myers Squibb procedures. Promotes safe practices and behaviors. Report immediately incidents to Environmental Health and Safety (EHS) department, participate in investigations and identify measures to prevent similar accidents in the future. Ensures that staff (including short duration and temporary contracts) is properly informed on hazards and trained to act in consequence. Promotes safe practices and behaviors, assure that EHS requirements are implemented and respected. Demonstrate Bristol Myers Squibb values. Performs other tasks as assigned. Qualifications & Experience Education and Experience BS or advanced degree in Chemistry, Biochemistry, Pharmacy, or relevant scientific discipline or equivalent combination of education, training and experience. Minimum 5 years of work experience in a GMP environment (pharmaceutical industry or similar field) 1-3 years of Quality Control Laboratory management experience prefer. Exceptional scientific and practical knowledge of analytical techniques (e.g., chromatography techniques (High-performance liquid chromatography, Ultra-performance liquid chromatography, Gas chromatography), Dissolution, UV/VIS, and IR techniques). Experience in executing quality control testing of solid oral dosage forms and raw materials. Exceptional knowledge of incoming material sampling and inspection. Working knowledge of relevant US, EU. and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participation of regulatory inspections. Experience with Laboratory Information Management System (LIMS), Learning Management System (LMS) and Enterprise Resource Planning System (ERP). Required Competencies: Knowledge, Skills, and Abilities Subject matter expert of Quality Control activities in the pharmaceutical industry with strong knowledge and interpretation of cGMP and regulations applicable to solid oral dose forms. Knowledge of Data Integrity and Good Documentation Practices. Ability to accurately understand, follow, interpret, and apply European Pharmacopeia and United States Pharmacopeia requirements and cGMP requirements. Exceptional technical writing skills. Work to improve efficiencies through process improvements Independent, adaptable, and highly motivated. Action-oriented and capable of setting priorities, managing timelines, and effectively managing changing priorities. Exceptional communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations. Ability to navigate through ambiguity and rapid growth and adapt to change the status quo. Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment. General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio) Fluent in English or French and professional command (minimum B2 level) of the second language (written and verbal) If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.Über das Unternehmen:1112 Celgene International SaRL

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary In this role you will share oversight of Quality Control (QC) activities related to Drug Product and Incoming Material to ensure compliance with internal policies, procedures, and regulatory requirements. This position will provide support for design, execution, troubleshooting and monitoring of QC process and testing activities pertaining to raw material (including sampling), stability, in-process, and bulk product. You will be responsible for cGMP compliance of the laboratory area and operations under your responsibility as well as for applying and ensuring staff complies with Environmental Health & Safety applicable procedures. Key Responsibilities Manage team and ensures cGMP compliance of the laboratory area and operations under responsibility. Create a positive and collaborative team environment and ensure that Bristol Myers Squibb standards are met. Manages performance and provides technical guidance, coaching and support to team members. Assigns training requirements and monitors training status of assigned team members. Create team plans to ensure resources are properly allocated and utilized effectively. Ensures all equipment used for GMP testing is in a qualified state. Authors, reviews, and approves complex GMP documentation such as laboratory procedures, work practices, plans, protocols, and reports. Support and sustains Lean Lab initiatives such as 5S, deviation reduction, Right First Time, and inspection readiness. Actively participates in inspections by Health Authorities. Report metrics to monitor schedule progress and help identify risk areas. Supports budget definition and adherence to budget target. Support purchase requisitions and purchase orders are managed as appropriate to ensure business needs are met in timely manner. Oversee QC incoming material, stability, in-process and bulk product testing activities. Collaborate cross-functionally and interdepartmental to define testing priorities, assign work to team members, and monitor progress against schedule. Ensure timely completion of stability samples in compliant with company procedures. Review and approve documentation as required by laboratory procedures. Perform final approval and disposition of QC results. Provide technical support to QC team members. Ensure compendial compliance of excipients (USP, Ph. Eur., JP and JPE as applicable) and evaluates any non-compendial supplier test methods against in-house methods and specifications. Defines incoming testing requirements of Incoming Materials, including specifications. Oversee sampling plan and testing regimes for all Incoming Materials. Provides oversight of testing contracted to external laboratories. Represents QC in cross-functional teams supporting New Product Introductions, Qualification and Risk Assessments. Support Deviations, Investigations and Change Control Management Ensures Deviations, CAPAs and Change controls are handled appropriately and in a timely manner. Initiates and/or implement changes in controlled documents. Own or lead investigations in collaboration with internal and external functions, as required. Approve laboratory investigations, checklists, and deviations as SME/Area Manager. Work with impacted QC area functions to define appropriate and effective corrective and preventive actions (CAPAs). Ensure timely and compliant closure of QC deviations/investigations and CAPAs according to Bristol Myers Squibb procedures. Promotes safe practices and behaviors. Report immediately incidents to Environmental Health and Safety (EHS) department, participate in investigations and identify measures to prevent similar accidents in the future. Ensures that staff (including short duration and temporary contracts) is properly informed on hazards and trained to act in consequence. Promotes safe practices and behaviors, assure that EHS requirements are implemented and respected. Demonstrate Bristol Myers Squibb values. Performs other tasks as assigned. If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.Über das Unternehmen:1112 Celgene International SaRL

Quality System Manager In the area of Quality Management, Regulatory & Medical Affairs at the Burgdorf site, we are looking for a technically and sound person as Quality System Manager | 80 - 100% Quality System Manager | Ref. No. 6530 Location: Burgdorf | Hybrid Help us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach. Your main tasks Organization and management of audits conducted by external parties (customers, Notified Bodies) and regulatory inspections Presenting topics related to design transfer, process validation and production during audits as an expert Planning and conducting internal audits as lead or co-auditor Support corrective actions to ensure effective implementation Collaborate with process owners and related departments to improve QMS processes at global and local level Ensure compliance of QMS processes with applicable requirements (e.g. ISO 13485, EU MDR, 21 CFR 820, MDSAP as well as specific requirements in the field). Supporting the timely implementation of new and amended requirements in the QMS processes Provide training, support and advice to Ypsomed's business units on requirements and QMS processes in the specialist areas: e.g. design transfer, product realization, change control, audit management, deviation management and document management Supporting Ypsomed's international subsidiaries in the application of QMS processes to fulfill requirements Support or lead projects related to quality management system improvement, certifications, implementation of processes at new international sites and expansion into new markets (e.g. USA) Your profile Technical, medical or scientific education Further training in the field of quality management of medical devices / GMP Experience in quality management in the life science sector (e.g. medical technology, pharmaceutical industry, biotechnology) Audit experience Experienced with quality management system software (e.g. TrackWise, SAP, etc.) Experience in working with authorities, Notified Bodies / site registrations would be an advantage Ypsomed - making the treatment of chronic diseases possible More than 2,000 employees worldwide develop and produce injection and infusion systems for self-medication with the Ypsomed Group. We are a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. With our market-leading products and solutions, we enable people all over the globe to self-treatment. Despite chronic diseases such as diabetes, obesity, or certain types of cancer, they are provided with the greatest possible quality of life. Contact Christoph Badertscher HR Recruiting Partner +41 (0) 34 424 34 58 Your future place of work Burgdorf Burgdorf

Bei Roche arbeiten 94-000 Menschen in über 100 Ländern an der Zukunft der Gesundheitsversorgung. Gemeinsam wurden wir eines der führenden, forschenden Pharmaunternehmen. Unser Erfolg basiert auf Innovation, Neugier und Diversität. Mit seinen 1400 Mitarbeitenden, stellt das Produktionszentrum Kaiseraugst die ununterbrochene Patientenversorgung mit qualitativ hochwertigen Medikamenten sicher. Es steht für die höchsten Standards der pharmazeutischen Herstellung, das größte, innovativste Verpackungszentrum der Roche und die Versorgung von mehr als 120 Ländern.Als Quality Assurance Manager - Change Control innerhalb der Quality Assurance for Quality Control Basel/Kaiseraugst sind Sie für die Betreuung aller Prozess- und Produkt relevanten Tätigkeiten im Bereich Change Control Analytics unter Berücksichtigung der gesetzlichen Anforderungen, GMP-Richtlinien und Roche Regelwerken sowie der Sicherstellung der Quality Oversight der QC Basel/Kaiseraugst zuständig.Dein Aufgabengebiet umfasst folgende Verantwortlichkeiten:Organisation eines GMP konformen und zeitgerechten Change Control Prozesses. Effiziente, fach- und termingerechte Ausübung der Funktion als Change Controller bei der Planung, Überwachung und Umsetzung von lokalen und globalen, analytischen Changes der kommerziellen QC Basel/Kaiseraugst. Verwaltung und Führung von Local Change Review Boards Verantwortlich für das Local Change Control-Prozedere der QC Basel/Kaiseraugst. Betreuung regulatorisch relevanter Changes und Autorisierung für die Einreichung von geringfügig regulatorisch relevanten Changes für die QC Kaiseraugst. Unterstützung der Quality Control-Gruppenleiter / - Beauftragter bei der Planung und Umsetzung von lokalen analytischen Changes (Planung, Erstellung und Verwaltung von Changes) Zusätzlich sind Sie Ansprechpartner für analytische Changes der QC Basel/Kaiseraugst und sind für die Erstellung, Prüfung und Implementierung von Vorgabedokumenten (SOPs) zuständig. Sie stellen diverse Themen vor in unterschiedlichen Gremien, sowohl lokal wie auch global (z.B. Global Change Commission, Validity Commission). Sie bearbeiten Projekte selbständig und arbeiten in lokalen und globalen Projekten mit. Sie unterstützen bei Inspektionen und bei der Bearbeitung von GMP-Issues (Deviations, CAPAs) sowie bei der Aus- und Weiterbildung neuer Kollegen*innen.Wer Du bistDu bist eine positiv denkende, integre und selbstreflektierende Persönlichkeit mit starken Team-Fähigkeiten. In diesem Sinne bringst du eine offene und kollaborative Einstellung und Denkweise mit, die es für die erfolgreiche Arbeit in deinen beiden Teams und bereichsübergreifend benötigt. Du vertraust dir und anderen, übernimmst Verantwortung und lebst eine offene Speak-Up- und Fehlerkultur. Deine lösungsorientierte Grundhaltung und Can-Do Einstellung bestimmt dein tägliches Handeln.Als Quality Assurance Manager*in QAfQC verfügst Du über eine mehrjährige Berufserfahrung in der pharmazeutischen Produktion, Entwicklung, Qualitätskontrolle oder Qualitätssicherung. Du hast einen Bachelor Abschluss in Pharmazie, Biowissenschaften, Naturwissenschaften, Ingenieurwissenschaften oder verfügst über eine entsprechende berufliche Ausbildung, kombiniert mit langjähriger Berufserfahrung in diesem Bereich.Des Weiteren besitzt Du folgende Kompetenzen und Fähigkeiten:Abgeschlossenes naturwissenschaftliches Hochschulstudium (e.g. in Pharmazie, Chemie, Biochemie) sowie Erfahrung in der Qualitätssicherung und/oder Qualitätskontrolle Fundierte internationale GMP Kenntnisse Routinierter Umgang mit IT-Systemen (z.B. Google-Anwendungen sowie QS-Systeme). Zeitliche Flexibilität Ausgezeichnete Kommunikations- und Teamfähigkeit sowie verhandlungssicheres Deutsch und Englisch in Wort und Schrift Du besitzt einen analytischen Arbeitsstil, der geprägt ist von Selbstverantwortung und Ergebnisorientierung. Du hast grosse Bereitschaft und Neugier, sich flexibel weiterzuentwickeln und im Sinne der Polyvalenz bereichsübergreifend zu lernen. Dazu gehört ein Interesse, vor- und nachgelagerte Prozessschritte zu erfassen und kennenzulernen. Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we-ve become one of the world-s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche Kaiseraugst is a cornerstone of Roche's global production and logistics network. It employs some 1900 people out of the 10,700 employees at our Basel/Kaiseraugst site and is Roche's largest and most innovative packaging facility worldwide. Read more.Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.Roche is an Equal Opportunity Employer.Roche Vakant seit : 08.02.2024 4303 Kaiseraugst (AG) 80% - 100% Nach Vereinbarung Unbefristet Sub Category Quality ValidationHiring Type Part timeJob Level Individual ContributorPosted Date 02-07-2024Posting End Date 03-06-2024Job Type Regular / PermanentThe Position

Quality Assurance Manager Im Bereich Quality Management, Regulatory & Medical Affairs in der Abteilung Quality Assurance suchen wir am Standort Solothurn eine kundenorientierte und qualitätsbewusste Persönlichkeit als Quality Assurance Manager | 80 - 100% Ref-Nr. 6367 Arbeitsort: Solothurn, Burgdorf | Hybrid Helfen Sie uns, modernste Medizintechnik-Lösungen auf den Markt zu bringen, indem Sie dank Ihrer strukturierten Herangehensweise Prozesse optimieren und die Qualität sicherstellen. Ihre Hauptaufgaben Sicherstellen der Qualitätsanforderungen für die Produktion von terminal sterilisierte Medical Devices sowie die dazugehörende technische Dokumentation gemäss ISO13485, MDR, CFR Part 820, produktspezifische Standards, nationale Guidelines und Gesetze für den gesamten Product Lifecycle im Verantwortungsbereich Koordination und Bearbeitung von Change Control Projekten und Aufrechterhaltung der dazugehörenden Dokumentation sowie Koordination und Bearbeitung von CAPAs im Verantwortungsbereich Review und Freigabe der Dokumente im Lifecycle Prozess (DMR, DHR) Ansprechpartner für Stakeholder aus den Bereichen Produktion, Entwicklung, und der Qualitätsorganisation Support und Teilnahme bei Behörden-, Kunden und Lieferantenaudits und die Bearbeitung bei Auditfindings Verantwortlich für die Reinraumbetreuung, inklusive Reinraummonitoring und Reinraumschulung von internem und externem Personal Unterstützung bei Sterilisationsprojekten mit Strahlensterilisation, verantwortlich für das Dose Audit Organisation und Bewertung von Daten zur Produktverbesserung Ihr Profil Abgeschlossenes technisches oder naturwissenschaftliches Studium (HF, Uni, FH) Mehrjährige Erfahrung in einer vergleichbaren Rolle im Bereich Medizinprodukte, Pharma oder Gesundheitswesen. Erfahrungen mit mikrobiologischen Prüfungen und Unterhalt von Reinräumen von Vorteil Erfahrung mit Business Software (SAP, Office, Jira, DOORs) Versiert in einschlägigen Qualitätsmethoden (Statistische Methoden, FMEAs, Lean Six Sigma, risikobasierte Entscheidungsfindung etc.) Eigeninitiativ und dienstleistungsorientiert Sehr gute Kommunikationsfähigkeiten in Deutsch und Englisch Darum Ypsomed - die Behandlung von chronischen Erkrankungen möglich machen Die weltweit über 2200 Mitarbeitenden der Ypsomed Gruppe entwickeln und produzieren Injektions- und Infusionssysteme für die Selbstmedikation. Wir sind ein erfolgreiches, rasch wachsendes, familiengeführtes Unternehmen mit Hauptsitz in Burgdorf (CH) und weltweit verschiedenen Produktionsstandorten und Tochtergesellschaften. Mit unseren marktführenden Produkten und Lösungen ermöglichen wir Menschen auf der ganzen Welt die Selbstbehandlung. Trotz chronischen Erkrankungen wie Diabetes, Fettleibigkeit oder gewissen Arten von Krebs erhalten sie damit grösstmögliche Freiheit. Kontakt Alain Rusconi Human Resources Expert Recruiting +41 (0) 34 424 28 64 Ihr zukünftiger Arbeitsort Solothurn Solothurn Burgdorf

The position is essential for ensuring the quality of the new product developments and maintaining the existing products; to ensure adequate product documentation and product control, guaranteeing data integrity, ensuring software reliability, building trust, facilitating continuous improvement. Quality Control Manager Role and Responsibilities: Assure high quality of our products throughout their entire lifecycle; Work close with R&D on new product developments and maintaining existing products – SaMD and non-medical Software Assure data accuracy and data integrity. Support product registrations. Complaint investigation in collaboration with R&D teams and customer support Lead or participate in Quality related project, where applicable Support to quality related processes, e.g. internal audits, supplier audits, external audits, CAPA management, training and others Requirements and Education: You hold a Bachelor’s or Master’s in engineering, computer science, life science or other related fields. Software background is a plus as well as a Lead Auditor certificate. You have a minimum of 5 years professional experience in new product development of medical devices, preferably SaMD; experience in quality management or regulatory affairs of medical devices, preferably in a Software environment. Key Required Skills, Knowledge and Capabilities: Knowledge of MDR, CFR FDA, MDSAP, ISO 14971, ISO 13485, IEC 62304 Good technical understanding of software Excellent communication and team player skills Independent and results-oriented way of working Fluency in English (written and spoken) – German is a plus Do you feel like joining us? Please apply today! Albisriederstrasse 2538074 Zurich

As a Quality Control Associate (a) you will be responsible for the sample management related activitiees:Coordinate movement and shipping of QC samples while ensuring confidentiality and adherence to standard operating procedures.Utilize LIMS and enterprise resource planning systems for sample management.Prepare shipment documents in collaboration with trade compliance and warehouse departments.Manage MS samples through TD LIMS and ensure compliance with QC requirements.Aliquot and sub-sample drug substance samples.Order, manage, and distribute QC reagents and consumables.Clean and distribute QC labware.Ensure GMP compliance of non-analytical testing equipment and perform cleaning activities.To be considered for this position, you must have:Apprenticeship or Bachelor's degree in a relevant scientific disciplineOptimally prior experience within a GMP Quality Control function and experience with purchasing quality controlled goodsFluency in German and EnglishProficiency in using laboratory information management systems (LIMS) and enterprise resource planning systemsStrong attention to detail and ability to manage complex sample management processes.Excellent organizational and time management skillsEffective communication and collaboration skillsAbility to work independently and in a team-oriented environment