Validation Manager
Torbay Pharmaceuticals
- Paignton, Devon
- Permanent
- Full-time
- Develop, implement, and manage validation master plans (VMPs) for equipment, processes, cleaning, and computer systems.
- Lead the creation, execution, and review of validation protocols (IQ/OQ/PQ) and reports, in conjunction with site SMEs.
- Lead validation efforts for sterile processing, cleanroom qualification, and sterilisation validation (e.g., autoclaves, SIP, CIP).
- Oversee environmental monitoring validation and critical utility validation (e.g., WFI, compressed air, HVAC).
- Ensure validation activities comply with GxP, FDA, EMA, and MHRA regulations.
- Manage risk assessments and change controls related to validated systems.
- Collaborate with cross-functional teams including QA, Engineering, Manufacturing, product Development, Quality Control and IT.
- Support internal and external audits and inspections by regulatory authorities.
- Maintain up-to-date knowledge of industry trends, regulatory changes, and best practices.
- Train and mentor validation staff and ensure continuous improvement of validation processes
- Bachelor’s or Master’s degree in Life Sciences, Engineering, Pharmacy, or a related field.
- Experience in pharmaceutical validation or quality assurance.
- Strong knowledge of validation principles, GxP, and regulatory guidelines (FDA, ICH, EU GMP).
- Experience with computer system validation (CSV) and process validation.
- Proficiency in validation documentation and electronic quality systems.
- Excellent analytical, organizational, and communication skills.
- Experience leading a team