Processes, equipment, capital projects, utilities, cleaning, and computer systems to ensure compliance with regulatory requirements (e.g., FDA, EMA, MHRA) and internal quality standards.
What you can expect in a Validation Manager role at TP:
1. Develop, implement, and manage validation master plans (VMPs) for equipment, processes, cleaning, and computer systems.
2. Lead the creation, execution, and review of validation protocols (IQ/OQ/PQ) and reports, in conjunction with site SMEs.
3. Lead validation efforts for sterile processing, cleanroom qualification, and sterilisation validation (e.g., autoclaves, SIP, CIP).
4. Oversee environmental monitoring validation and critical utility validation (e.g., WFI, compressed air, HVAC).
5. Ensure validation activities comply with GxP, FDA, EMA, and MHRA regulations.
6. Manage risk assessments and change controls related to validated systems.
7. Collaborate with cross-functional teams including QA, Engineering, Manufacturing, Product Development, Quality Control, and IT.
8. Support internal and external audits and inspections by regulatory authorities.
9. Maintain up-to-date knowledge of industry trends, regulatory changes, and best practices.
10. 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.
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