QA Manager (m/f/d)

Firmenname für PREMIUM-Mitglieder sichtbar

  • Juni 2024
  • nicht angegeben
  • CH-Basel
  • auf Anfrage
  • 12.05.2024
  • 759982/1-en

Projekt Insights

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Ihre Aufgaben:
• 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

Ihre Qualifikationen:
• University Degree in Engineering, Pharmacy, Biology, Biochemistry, Chemistry, Life Science, Pharmacy or equivalent
• Proven 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

Ihre Vorteile:
• Unlimited contract possible
• A very renowned company

Projektdauer: unbefristet

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