QA Manager (m/f/d)
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 18 months.
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. The QA Manager will support other QA managers in their daily work, in order to enable them to participate in the preparation for the introduction of a new global operational supply management application. The person will collaborate as a QA manager in close partnership with all involved parties, mainly at the Clinical Supply Centre Parenterals and at the Quality Control laboratories.
- Acts as a delegate of the Swiss RP for IMPs
- Has the QA responsibility for GMP compliance of manufacture and analysis of IMP batches (in particular parenteral drug product batches)
- Reviews and approves GMP procedures, records and reports (e.g. SOPs, master batch records, discrepancy and change records and validation reports)
- Performs self-inspections in GMP plants and laboratories at Roche Basel
- BS/MS/PhD Degree in Pharmacy, Biology, Biochemistry, Chemistry, Life Science or equivalent
- Min. 3 years experience in activities around parenteral manufacturing and quality control
- Min. 3 years experience in a GMP regulated environment
- Experience in Discrepancy Management, CAPA, Technical Change Management (Veeva Vault) and Manufacturing Management (SAP), MES (PMX) and LIMS is an additional plus
- Fluent in German and English min. B1
- 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 independently and in a team 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
- Project management skills
- Proficient contribution to health authority inspections and internal GMP audits
Are you interested? Do not hesitate and submit your complete application documents online today.
We also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!
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Kontakt
Adnan Ferizi
Arbeitsort
Basel
Pensum
80 - 100%
Position
Mitarbeiter
Branche
Industrie + Produktion
Address
Work Selection