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Lead QA Officer

Are you that experienced Quality Assurance professional? And are you looking for a senior QA position that has it all? From advising to consulting to managing to training to compliance to improvement? This is the job for you!

Job Description
As a Senior QA Officer you will work at a very promising and growing international pharmaceutical and biotechnological company in the Utrecht area. This biotech organization, where cutting-edge therapies are being developed, tested in clinical trials, and produced, both in-house and with the help of CRO's and CMO's, is rapidly expanding. Therefore, their QA department will also expand, and they are looking for a Quality Assurance expert on anything GxP related, especially on GMP regulation. Your job will have a very broad scope, dealing with everything from QMS improvement and maintenance, to activities such as audits, capa's and changes, training employees, batch release, and more.

Responsibilities

  • Assessing GMP and GCP related activities such as validations, internal and external audits, deviations, GxP documentation and batch release.
  • Managing the Quality Management System, maintaining and improving it
  • Performing internal and external audits at partners (CMO's, CRO's)
  • Overseeing QA activities and providing counsel and advice, both wanted and unwanted
  • You report directly to the QP, Qualified Person, and most of your responsibilities are your own

Requirements

  • MSc or PhD degree in biotechnology, or similar, or extensive knowledge thereof
  • Several years of experience with Quality Assurance in a GMP and/or GCP setting
  • Extensive knowledge of GxP regulation, with experience as an auditor
  • Fluent in English, Dutch is a plus
  • Assertive, pragmatic, and analytical

Benefits

  • Contract: 1 year followed by long term contract
  • Salary indication: €50.000 - 90.000 - depending on experience
  • Working hours: 32 - 40 hours per week
  • Location: Utrecht area
  • Vacancy number: 17059

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Als gespecialiseerde partij hebben wij een groot aanbod aan laboratorium vacatures op het gebied van Quality Control (QC) en Research &Development (R&D) binnen diverse sectoren, waaronder de Farmaceutische industrie, Biotechnologie, Contract Manufacturing, Contract Research, Voedingsmiddelenindustrie, Chemie, Milieu en Plantensector.