QA Manager

vor 1 Monat


Basel, Basel-Stadt, Schweiz Randstad Vollzeit
For our client, an international pharma company in Basel, we are looking for a QA Manager to support and oversee the end to end cGMP activities in implementation of Annex 1 requirements at the Clinical Supply Centre Basel. They take care that the Right to Operate can be maintained by ensuring that quality and compliance requirements according to Health Authority expectations and Company Standards for IMP products are given after the successful implementation of Annex 1.

The perfect candidate has sound Quality Assurance knowledge and experience in the area of Annex 1 implementation, sterile Drug Product Manufacturing, Qualification and Validation as well as parenteral manufacturing activities.

General Information:Start date: ASAPPlanned duration: 1 yearExtension: very likelyWorkplace: BaselWorkload: 100%Home Office: only by exceptionsTravel: noTeam: 8-15 people Working hours: Standard

Tasks & Responsibilities:Support and drive implementation of Annex 1 requirements during implementation in the Clinical Supply Centre for sterile Drug Product (Parenterals) within IMP Switzerland.Responsible to represent Quality Assurance while driving all activities related to a successful implementation of Annex 1 within IMP Quality Operations SwitzerlandMaintaining and continuously supporting all Qualification/Validation and parenteral manufacturing activities within IMP Quality Operation SwitzerlandSupport and collaborate with Quality Assurance Managers within IMP Quality Operations SwitzerlandProvide sound technical and quality assurance expertise for review and approval of quality related documents (e.g. SOPs, qualification, validation documents)Partner with all stakeholders within the Clinical Supply Centre as well as with Technical Development and provide guidance to ensure successful delivery of the Annex 1 implementation goalsSupport your area of responsibility at HA inspections and internal audits
Must Haves:
BS/MS/PhD Degree in Engineering, Pharmacy, Biology, Biochemistry, Chemistry, Life Science, Pharmacy or equivalentMin. 2-5 years experience in a GMP regulated environment and with Quality Systems, Quality assurance and OTExperience in Quality Risk Management as well as in performing risk assessments (e.g. FMEA)Experience in Qualification / Validation as well as all all activities around parenteral manufacturingFluent in German, English B2Fast 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 resultsExcellent 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:
Experience with Annex 1Experience in Discrepancy Management, CAPA, Technical Change ManagementProject management skillsProficient contribution to health authority inspections and internal GMP audits
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