For this booming Biotech client, I am looking for a Senior Validation Specialist to review and approve documentation and who oversees qualification and validation for lab equipment. The initial project is 6 months but I am also open to candidates that are looking for a permanent position.
- Overseeing Biotech equipment qualification validation activities (Flow Cytometers, PCR, Centrifuges, Waterbeds, Spectrophotometers)
- Overseeing validation life cycle documentation and qualification deliverables:
- Review and approve qualification and validation plans;
- Review and approve validation documentation associated with equipment, facilities and utilities (URS, DQ, IQ, OQ, PQ).
- Assure requirements traceability throughout the whole project validation file (from URS to PQ) and performing validation impact assessments prior to implementation of changes.
- Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs and all aspects of safe, reliable and consistent operation of the system.
- Support the production & technical services teams in the implementation of the validation activities.
- Ensure the adequate management of validation deviations (be QA GMP Responsible) and potentials CAPA (be Compliance Authority).
- Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.
- Degree in LifeSciences and preferably around 10 years of experience.
- Experience in overseeing Biotech equipment qualification validation activities
- Understanding of cGMPs, GAMP, ICH Q7A and validation practices (IQ/OQ/PQ) and their application in practice.
- Preferably an engineering background. Position is not hands-on, but the technical hands-on experience is required.
- 1st of July (flexible)
- 6 month contract OR permanent contract
If you’re interested in the above description, please apply with your CV. For further information, please contact Merel van Os at +31 (0)20 20 44 502 or by email at firstname.lastname@example.org