Quality Assurance (QA) Compliance Expert
Prismond Group SA
Zurich, Switzerland
vor 20 Tg.

Role & Responsibilities

In your role as a Prismond Compliance expert, you are supporting our clients and project teams by :

  • Harmonization of (Global) Quality Management Systems
  • Gap Analyses of the Q-Manuals against relevant Guidelines and Regulations
  • Developing and implementing QMS (Policies / SOPs) improvements of our clients
  • Review and correction of SOP landscapes
  • Writing of Global Quality Standards
  • Ensure complied documentation systems of our clients
  • Writing Quality risk management (QRM) concepts with the corresponding SOPs, templates and tools
  • Conception and Implementation of Supplier Quality Agreements
  • Handling of Change Control Requests, Non-Conformities and CAPAs, ensuring their adequate and timely closure from QA perspective
  • Supplier and Internal Audits including Mock-Inspections
  • Planning and moderation of QA workshops and training events
  • Support tech transfer and analytical method transfer activities
  • Position Requirements

  • University degree in Quality, Engineering, Sciences or another relevant discipline
  • At least 2-3 years of experience within a GMP-regulated environment, preferably in the Pharmaceutical or Medical Devices industry
  • Broad working knowledge of Quality Management Systems, cGMP and ICH Q9 regulations; basic understanding of manufacturing and supplier process
  • Analytical and structured working style; strong attention to detail
  • Ability to effectively work as part of a multidisciplinary, international team
  • Good verbal and written communication skills in English, German language is a plus
  • Hands-on personality, with flexibility and dedication to maximize our client s value
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