VQ Life Sciences are recruiting for a Permanent Validation and Regulatory Manager in the Northwest. This is a client facing position with projects throughout the UK.
You will be required to provide Validation and Regulated support for the completion of projects including: CAPEX, New Builds, Facility Expansions, Cleanrooms.
This is very much a hands on management position, leading by example and clear communication is essential.
- Implement validation systems and validation strategies
- To work alongside project teams to provide validation and regulatory guidance
- Provide validation and regulatory support throughout Design – Construction – Commissioning stages
- Ensure company is compliant with industry regulations and guidelines
- Creation of URS’s
- Generation of protocols: DQ, IQ, OR and PQ
- Manage validation team and validation activities related to projects and internal processes
- Work closely with regulators/inspectors (FDA, MHRA)
- Project relevant validation and regulatory training
- Work very closely with Clients, Internal Teams, Suppliers and Sub-Contractors
- Provide validation management for projects including but no limited to: Cleanrooms, HVAC Systems, Utilities, Sterilisers, New Builds.
- Held a Validation Manager position previously within the Pharmaceutical industry for at least 5 years.
- Degree qualified BSc/BEng or equivalent
- GMP background within the Pharmaceutical industry
- Knowledge and experience with Validation activities such as: Process, Facilities, Utilities, Equipment and CSV.
- Strong communicator at al levels
- Knowledge of regulatory guidelines and changes (FDA, MHRA), GMP, GAMP
- Managed Validation and Commissioning teams
- Happy to travel UK wide
If you’re a Validation Manager with 5+ years within the Pharmaceutical industry, live in the Northwest and looking for a new Permanent position, please get in touch with VQ Life Sciences for more information.
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