QA Manager

vor 2 Wochen

Basel, Schweiz Work Selection Vollzeit

**Beschreibung**:
For our international medical partner, F. Hoffmann-La Roche Ltd. in Basel, we are looking for a qualified and motivated **QA Manager** for a temporary contract of 12 months with a possible extension.

The IMP Quality Operations Unit Switzerland in Global Technical Operations is the Quality partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality, Quality Systems and GMP-compliance oversight of all Investigational Medicinal Products (IMPs) manufactured and packed for clinical studies in Switzerland.

You support the end to end Quality Systems activities including IT systems maintaining the Right to Operate at the Swiss Technical R&D sites and in ensuring quality and compliance of IMP products according to Health Authority requirements and Company Standards for IMP products. You also Support Business Process Management of the Release Quality System CLARA with special emphasis on batch tracing activities.

**Tasks**:

- Running, maintaining and continuously improving the Quality Systems business processes (Focus: Discrepancy Management, CAPA, Technical Change Management)
- Support the business process of the Release Quality System CLARA with special emphasis on batch tracing activities
- Partner with IT, other quality functions and supply chain in projects regarding introduction of new IT Systems. Representation of the IMPQ CH in cross functional teams
- Openness for other quality related activities within IMPQ CH

**Must Haves**:

- Min. Bachelor's Degree in Chemistry, Life Science, Engineering, Pharmacy, IT or equivalent
- Min. 3 years experience in a GMP regulated environment
- First experience with Quality Systems, Quality assurance or OT (Discrepancy Management, CAPA, Technical Change Management)
- Fluent in both German and English
- Fast learner, strong team-player with a high level of self-motivation and with ability to prioritize, simplify and connect the dots
- Proven ability to work towards results, excellent planning and organizing skills in order to manage multiple tasks at the same time as well as analytical capabilities and an innovative manner of solving problems

**Nice to Haves**:

- Project management skills
- Experience in Pharmaceutical Industry
- Performance in health authority inspections and internal GMP audits

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