QA Validation Specialist

QA Validation Specialist - CPV

Location: Waterford | Contract: Initial 12 months

A global biopharmaceutical company based in Waterford is seeking a QA Validation Specialist to support the review and compliant implementation of Continued Process Verification documentation.

This mid-level contract position would suit a Quality Assurance or Quality Validation professional with experience reviewing validation documentation in a GMP-regulated pharmaceutical or biopharmaceutical environment.

The Position

You will support site Quality and validation resources throughout the implementation of the CPV programme.

Responsibilities will include:

• Reviewing CPV documentation for completeness, accuracy and alignment with global guidance.
• Supporting GMP compliance and Quality Systems requirements within the CPV workstream.
• Reviewing validation and process-monitoring documentation.
• Supporting CAPA and quality risk-assessment activities.
• Contributing to regulatory inspection-readiness preparations.
• Working with MSAT, Production, QC and Data Science teams to ensure documentary consistency.
• Identifying and supporting the resolution of quality and documentation gaps.

Requirements

• Quality Assurance or Quality Validation experience within a GMP environment.
• Experience reviewing validation or CPV documentation.
• Strong knowledge of pharmaceutical Quality Systems.
• Experience with CAPA and quality risk assessment.
• Knowledge of FDA inspection-readiness requirements.
• Strong controlled-documentation and technical review skills.
• Pharmaceutical, biopharmaceutical or biotech industry experience.

The role is currently fully site-based in Waterford, five days per week.

Interested? Apply now or contact Kerry Rickard for further information.