EINFÜHRUNG
Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competences within the Interiman Group, we offer tailor-made solutions in personnel consulting.
For our client F. Hoffmann - La Roche in Basel, we are looking for a motivated and reliable (m/f/d)
IMP Quality Manager 80-100%
AUFGABENBESCHREIBUNG
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
Reports directly to the RP and RP deputy
ERFORDERLICHES PROFIL
Bachelor or Master Degree in Life Sciences or equivalent
Min. 3 years of relevant experience in the pharmaceutical industry
Min. 3 years experience in a GMP regulated environment
Min. 3 years experience all activities around parenteral manufacturing and quality control
Demonstrated experience in a Pharmaceutical Technical Development environment
Knowledge of cGMP and Quality requirements for clinical development stages of biotechnological and/or parenteral IMPs (e.g. EU Annex 1)
Experience in Discrepancy Management, CAPA, Technical Change Management (Veeva Vault) and Manufacturing Management (SAP), MES (PMX) and LIMS is an additional plus
Fluent in English (C1) and German (C1), with clear and professional communication skills
Fast learner, strong team player with a high level of self-motivation
Proven ability to work independently and in a team towards results
Excellent planning and organizing skills
Nice to Have: Project management skills
Proficient contribution to health authority inspections and internal GMP audits
Start date: asap - latest: 01.09.2025
Planned duration: 12 months
Extension: very likely
Home Office: max. 20%
Are you interested and would you like to seize this opportunity? Then we should definitely get to know each other! Simply click on "Apply now" and we look forward to receiving your complete application documents.