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Principal Validation Specialist
3 months ago
Competitive salary plus great benefits
Holmes Chapel, UKKEY RESPONSIBILITIES**:
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Protocol Authorship & Execution: Author and execute protocols for various validation and lifecycle management activities, ensuring compliance with relevant standards and regulations.
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Process Validation (PV): Oversee and execute process validation activities for commercial processes and development projects including technology transfers.
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Cleaning Validation (CV) & Verification (CVerif.): Manage cleaning validation and verification processes, ensuring the cleanliness of manufacturing equipment and environment.
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Equipment Qualification (EQ): Responsible for the qualification of both large and small manufacturing equipment, including Commercial off-the-shelf (COTS) and bespoke items.
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Temperature Mapping: Conduct temperature mapping across various storage locations such as warehouses, storage cabinets, and cold rooms.
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Validation Document Review: Review and approve validation documents generated by other functions like the Technical Support Group. Act as a validation SME, providing guidance on standards, requirements, and validation strategies.
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Product Quality Reviews (PQR): Compile and coordinate annual PQRs for assigned products, ensuring continual product quality.
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Cleaning Process Reviews: Responsible for compiling periodic Cleaning Process Reviews for assigned processes, including performing cleaning verification (via chemical or micro swabbing).
Estimated 80% of the time
Qualification & Validation:
The role involves ensuring that all site processes and equipment are validated or qualified compliantly with maximum effectiveness and efficiency.
Key tasks include:
- Overseeing the status of qualified/validated processes, equipment, and systems across the site.
- Executing validation packages and reporting promptly, with mínimal disruption to manufacturing and testing schedules, whilst maintaining compliance.
- Leading, organising, and supervising investigations into identified deviations using established procedures. Formulating recommendations for mitigating actions to prevent recurrence and participating in training of associates when necessary.
- Ensuring that new products, their related processes, and systems, are qualified/validated in compliance with GxP and adhere to industry standards for process robustness.
- Preparing GMP documentation, including but not limited to, quality risk assessments (QRA), validation protocols and reports (URS, FRS, DQ, IQ, OQ, PQ, PV, CV), validation master plans, validation deviations, events/deviations, investigational protocols, and technical reports.
Estimated 20% of the time
Compliance & Product Maintenance:
Ensuring compliance for all relevant systems and activities across the site by:
- Ensuring all GxP equipment, methods, and processes remain fully qualified/validated.
- Delivering training across the site to maintain a compliant and robust validation system, and to support the handover of validation activities.
- Preparing and reviewing Standard Operating Procedures and associated documentation for issue and implementation.
- Coordinating and compiling annual Product Quality Reviews (PQR) and Cleaning Process Reviews.
- Maintaining daytoday compliance.
