Job Details

Quality Control Qualification and Validation Specialist

  • ₣Competitive
  • Bern, Switzerland
  • Contract
A world renowned pharmaceutical company are searching for an experienced Quality Control Qualification and Validation Specialist to act as CSV SME for the Quality Control department.

What will you be doing?
  • Archival of QC Analytical equipment’s electronic data according to Pharma regulations, site procedures and IT policies.
  • Definition of the validation strategy and compliance activities required for archival of electronic data.
  • Coordination of computerized system qualification and validation activities within the Quality Control department.
  • Perform and/or support the writing of specification documents (URS).
  • Review test protocols, plans and reports.
  • Support test execution.
  • Support and train team members in CSV methodology.
  • Supporting the timely and effective completion of investigations, change controls and CAPA’s.

What do you bring to the table?
  • Graduate degree in chemistry, biotechnology, or related degree.
  • Extensive demonstrable computerized system validation (CSV) experience, including good knowledge of related regulatory requirements (GAMP 5, 21 CFR part 11, etc.).
  • Strong working GMP knowledge.
  • English (fluent), and German (desirable).
Robyn O'Toole Recruitment Consultant

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