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Imp quality manager

Basel
Flexsis AG, IT-GITR
Qualitätsmanager
Inserat online seit: Veröffentlicht vor 10 Std.
Beschreibung

EINFÜHRUNGFlexsis 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%AUFGABENBESCHREIBUNGActs as a delegate of the Swiss RP for IMPsHas 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 BaselReports directly to the RP and RP deputyERFORDERLICHES PROFILBachelor or Master Degree in Life Sciences or equivalentMin. 3 years of relevant experience in the pharmaceutical industryMin. 3 years experience in a GMP regulated environmentMin. 3 years experience all activities around parenteral manufacturing and quality controlDemonstrated experience in a Pharmaceutical Technical Development environmentKnowledge 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 plusFluent in English (C1) and German (C1), with clear and professional communication skillsFast learner, strong team player with a high level of self-motivationProven ability to work independently and in a team towards resultsExcellent planning and organizing skillsNice to Have:Project management skillsProficient contribution to health authority inspections and internal GMP auditsStart date: asap - latest: 01.09.2025 Planned duration: 12 months Extension: very likelyHome 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.

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