Validation Specialist

Zurich, Canton of Zürich (CH)
Dependant Upon Experience
11 Jun 2021
11 Jul 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
  • Ensure regulatory compliance through Validation & Qualification.
  • Responsible for determining processes requiring validation with a risk based approach.
  • Experience in preparing protocol and execution for validation/qualification on multiple products with responsibility across equipment / production /packaging/ facilities & utilities / Analytical Methods / cleaning studies.
  • Development of validation strategy in accordance to international regulatory standards cGMP.
  • A good working understanding of Scientific & Risk Based Approaches to qualification and experience in conducting root cause analysis and FMEA activities (ICH Q9).
  • The ability to understand and adhere to cGMP, safety guidelines and accurate documentation of qualification and validation.
  • Technical Documentation skills (URS, FDS, DQ, VMP, IQ,OQ,PQ, PV, CPV, FAT, SAT).
  • Knowledge and understanding of Eudralex Vol 4, FDA 21 CFR Part 11, ICH Q7.