QA Manager

vor 1 Monat

Basel, 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: ASAP
  • Planned duration: 1 year
  • Extension: very likely
  • Workplace: Basel
  • Workload: 100%
  • Home Office: only by exceptions
  • Travel: no
  • Team: 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 Switzerland
    • Maintaining and continuously supporting all Qualification/Validation and parenteral manufacturing activities within IMP Quality Operation Switzerland
    • Support and collaborate with Quality Assurance Managers within IMP Quality Operations Switzerland
    • Provide 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 goals
    • Support 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 equivalent
      • Min. 2-5 years experience in a GMP regulated environment and with Quality Systems, Quality assurance and OT
      • Experience 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 manufacturing
      • Fluent in German, English B2
      • 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
        Nice to Haves:
         
        • Experience with Annex 1
        • Experience in Discrepancy Management, CAPA, Technical Change Management
        • Project management skills
        • Proficient contribution to health authority inspections and internal GMP audits

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