Technischer QA Manager für Anlagen und Systeme — Roche

Full description

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. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position Our IMP Quality Qualification/Validation team plays a central role in ensuring GMP compliance of equipment and systems used for the production of test preparations (IMPs) in Basel and Kaiseraugst. The team covers production facilities for chemical synthesis, solida formulation, sterile filling, packaging and analytics as well as CSV systems. With us, you will get an insight into the production of clinical investigational drugs from the active ingredient to the formulation up to the packaging. We are looking for a dedicated and motivated personality as Technical QA Manager to strengthen the team in the area of quality oversight of plants, equipment, infrastructure, rooms and computer systems. The focus is on companies producing solid drug forms for clinical trials and packaging clinical investigational medicinal products.

The possibility In this role, you take on exciting and responsible tasks in quality management:

• QA Oversight of qualification and validation activities for GMP-relevant facilities (focus on solid drug forms and packaging) and for simple CSV systems (GAMP 5 Category 1 & 3).
• Support in implementing data integrity requirements and maintaining the right to operate through end-to-end cGMP activities.
• Review and approval of GMP documents such as qualification plans, CAPAs, SOPs, change/deviation management and risk analysis.
• Perform deep root cause analyses to solve complex problems.
• Promoting optimization and improvement activities within IMP Quality.
• Close cooperation with stakeholders to achieve common goals.
• Represent your area of responsibility for inspections by health authorities and internal audits.

Who you are

To succeed in this position, you ideally bring the following qualifications:

• Academic degree in engineering, chemistry, life science, pharmacy or a comparable qualification.
• At least 5 years of experience in the pharmaceutical industry, of which at least 2 years in QA, as well as comprehensive practice in plant/device qualification (Annex 15) and CSV (Annex 11).
• An in-depth understanding of global quality and GMP requirements, up-to-date data integrity standards (DI) and experience with regulatory inspections and internal audits.
• Strong team player with excellent communication and influence skills as well as curiosity and willingness to take on responsibility.
• Flowing knowledge of German and English in words and writing.

Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!

Who we are A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an equal opportunity employer.