Quality Assurance Manager

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Quality Assurance Manager

 

GxPeople is currently working with a global client who is seeking a Quality Assurance Manager to join their team in Germany.

 

Responsibilities

  • Develop and maintain Quality/Technical Agreements to align with legal contracts and regulatory requirements.
  • Management of high impact exception events and CAPA ensuring events are appropriately assessed
  • Review and approval of relevant Product Quality Reviews to ensure accuracy and completeness and management of actions to address any identified trends.
  • Review and approval of complaint investigations arising from Contract Manufacturing Operations(CMO)/Supplier manufactured product and follow-up on complaint trend investigations for non-medical and medical (adverse events) complaints.
  • Management of all changes related to CMO/Suppliers which have a quality or regulatory impact, ensuring timely communication & implementation of changes in line with regulatory requirements.
  • Maintain a Quality Management Review program and Quality Performance Measurement for CMOs / Suppliers, that identify and address quality, operational, and organizational issues.
  • Participate on QA cross-functional teams to support CMOs, including active participation in Business Management Reviews or Workstreams, as necessary.


Qualifications and Experience

  • Academic background in a relevant scientific discipline or other technical/scientific
  • Minimum 7 years in QA, operations or pharmaceuticals engineering
  • Excellent communication skills
  • Leadership experience
  • Fluent in English and German


For more information or, if you’d like to be considered for this position please call us on +44 20 3637 4393 or email enquiries@gxpeople.com.

 


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