QA Manager - Qualification and Validation of Systems, Devices and Systems — Roche
NewCHF 68'000 - 103'000
Roche · Basel (BS)
- Location
- Basel
- Contract
- full-time
- Posted
- 3 days ago
SalaryCHF 68'000 - 103'000
Role overview
Roche QA Manager Position
At Roche you can show up as yourself, embraced for the unique qualities you bring.
Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
- Roche QA Manager Position
- At Roche you can show up as yourself, embraced for the unique qualities you bring.
- We are looking for an engaged and experienced professional as QA Manager to strengthen our team in the Lifecycle Management of Equipment, Devices, and Systems. Our IMP Quality
- Qualification/Validation team plays a central role in ensuring the GMP compliance of equipment and systems used for the production of Investigational Medicinal Products (IMPs) in Basel and Kaiseraugst.
- As the ideal candidate, you bring a strong quality awareness and the following profile: - Education & Experience: Academic degree in engineering, chemistry, life science, pharmacy (or equivalent) and at least 5 years of experience in the pharmaceutical industry (of which at least 2 years in QA). - Qualification Expertise: Comprehensive practical knowledge in equipment and device qualification and validation according to Annex 15. - CSV & Data Integrity: Solid experience in Computerized Systems Validation (CSV) according to Annex 11 and a deep understanding of current data integrity requirements. - Audit Expertise & GMP: Solid knowledge of global quality and GMP requirements and proven success in GMP audits and authority inspections. - Soft Skills & Languages: Strong team player with excellent communication and influencing skills; fluent German and English skills (spoken and written) are required.
Main responsibilities
- We are looking for an engaged and experienced professional as QA Manager to strengthen our team in the Lifecycle Management of Equipment, Devices, and Systems. Our IMP Quality
- Qualification/Validation team plays a central role in ensuring the GMP compliance of equipment and systems used for the production of Investigational Medicinal Products (IMPs) in Basel and Kaiseraugst.
- The team covers production equipment for chemical synthesis, solid formulation, sterile filling, packaging, and analytics, as well as CSV systems.
- In this diverse role, you will be responsible for the quality assurance and monitoring of complex qualification and validation processes to ensure global GMP standards are met at our sites.
- Possibilità To succeed in this role and drive our quality standards forward, you will take on the following key responsibilities: - QA Oversight: Ensure quality assurance for qualification and validation activities for GMP-relevant equipment and systems (focus on laboratory devices, "off-the-shelf" computer systems, and simple CSV systems according to GAMP 5 category 1 & 3). - Document Review: Responsibility for reviewing and approving critical GMP documents such as qualification plans, reports, SOPs, and risk analyses. - Quality Management: Control and approval of change and deviation management, CAPAs, and the conduct of in-depth root cause analyses to solve complex problems. - Compliance & Data Integrity: Support the implementation of data integrity (DI) requirements and maintain the "Right to Operate" through end-to-end cGMP activities. - Optimization: Actively drive process optimizations and improvement activities within the IMP Quality area. - Interface: Close collaboration with internal stakeholders to achieve common goals. - Audit & Inspection Support: Representative coverage of your area of responsibility during internal audits and inspections by health authorities.
Key requirements
- As the ideal candidate, you bring a strong quality awareness and the following profile: - Education & Experience: Academic degree in engineering, chemistry, life science, pharmacy (or equivalent) and at least 5 years of experience in the pharmaceutical industry (of which at least 2 years in QA). - Qualification Expertise: Comprehensive practical knowledge in equipment and device qualification and validation according to Annex 15. - CSV & Data Integrity: Solid experience in Computerized Systems Validation (CSV) according to Annex 11 and a deep understanding of current data integrity requirements. - Audit Expertise & GMP: Solid knowledge of global quality and GMP requirements and proven success in GMP audits and authority inspections. - Soft Skills & Languages: Strong team player with excellent communication and influencing skills; fluent German and English skills (spoken and written) are required.
Application process
- now to explore this exciting opportunity!
Contacts
- Ready for the next step?
- We look forward to hearing from you.
Additional details
- QA Manager Position
- Descrizione At Roche you can show up as yourself, embraced for the unique qualities you bring.
- Mansioni We are looking for an engaged and experienced professional as QA Manager to strengthen our team in the Lifecycle Management of Equipment, Devices, and Systems.
- Requisiti As the ideal candidate, you bring a strong quality awareness and the following profile: - Education & Experience: Academic degree in engineering, chemistry, life science, pharmacy (or equivalent) and at least 5 years of experience in the pharmaceutical industry (of which at least 2 years in QA). - Qualification Expertise: Comprehensive practical knowledge in equipment and device qualification and validation according to Annex 15. - CSV & Data Integrity: Solid experience in Computerized Systems Validation (CSV) according to Annex 11 and a deep understanding of current data integrity requirements. - Audit Expertise & GMP: Solid knowledge of global quality and GMP requirements and proven success in GMP audits and authority inspections. - Soft Skills & Languages: Strong team player with excellent communication and influencing skills; fluent German and English skills (spoken and written) are required.
- Contatto Ready for the next step?
- Apply now to explore this exciting opportunity!
Notes and original content
- Our IMP Quality
