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Computer Systems Validation Specialist

  1. Brussels
  1. Contract
Competitive
24807
  1. Commisions, Qualification and Validation
Date Posted11 May 2020
Senior CSV Specialist - Global Pharmaceutical Client – 7 Month Contract in Brussels, Belgium

Our client, one of the worlds largest pharmaceutical organisations is responsible for developing and manufacturing medicines, consumer products and vaccines for a wide range of medical disciplines. They have been responsible for the development of several key and revolutionary products and have a presence in the USA, EU and Asia-Pacific.

With continued organisational growth and a considerable amount of investment across the portfolio and capital programme, they are currently seeking the expertise of CSV Specialist with extensive experience automated systems experience to join their team.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:

  • Writing, reviewing, and approving of validation plans and validation summary reports
  • Reviewing and approving of Technical Change Description
  • Reviewing and approving of IQOQ protocols & reports, PQ protocols & reports
  • Reviewing of CVS specific SOP’S and Templates
  • Ensure the proper execution of the qualification and validation activities with respect of the  internal validation methodology
Requirements:
  • University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
  • Certification in computer system validation or equivalent is a plus.
  • Fluent in French and English is advantageous
  • Extensive experience in a computer systems validation role working on automated systems such as PLC, HMI, SCADA, DeltaV, Archestra.
  • CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11)
  • Validation practices and guidelines (life cycle approach, ICH, ASTM E2500)

If you are interested in this role, please apply now for more information!

 

 

 





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