Overview
QA Validation Specialist Jobs in Waterford, County Waterford, Ireland at FRS Recruitment
Title: QA Validation Specialist
Company: FRS Recruitment
Location: Waterford, County Waterford, Ireland
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.
Skills:
Continued Process Verification (CPV) GMP Quality Assurance CAPA Quality Risk Assessment
Benefits:
Negotiable
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