Validation Coordinator

AssureBio is partnering with a UK-based pharmaceutical manufacturer to appoint a QA Validation Coordinator into a technically strong Quality & Regulatory function.

This role is ideal for a detail-driven QA or Validation professional who enjoys working across manufacturing, QC, engineering, and regulatory teams, owning validation frameworks that underpin compliant, reliable product supply.

If you like turning complex data into clear validation evidence, this is a role where your work directly supports QA and inspection readiness.

Responsibilities

As QA Validation Coordinator, you will support technical QA leadership by coordinating and maintaining site-wide validation, qualification, and calibration programmes across manufacturing and packaging operations.

You’ll be a central point of reference for validation status, historical data, and technical documentation, working closely with QA, QC, Engineering, and Operations.

Key responsibilities include:

• Ownership and maintenance of the Validation Master Plan (VMP) and key validation frameworks
• Coordinating process, cleaning, analytical method, stability and hold-time validation activities
• Supporting continuous process verification (CPV) and periodic re-validation reviews
• Managing validation inputs into Annual Product Quality Reviews (APQRs)
• Ensuring validation work reflects routine manufacturing and packaging batches
• Supporting new product introduction and technical change activities
• Raising and supporting deviations linked to validation or GMP issues

Technical Focus Areas

• Manufacturing & packaging process assessment (e.g. blending, granulation, compression, coating, packaging)
• Cleaning validation and contamination control strategies
• Analytical method validation (non-pharmacopoeial where required)
• Stability study coordination, reporting and trending
• Statistical analysis and data review (e.g. CpK, trending, datasets)

Key Experience

• Life science degree (or equivalent scientific background)
• Experience across QC, QA, Manufacturing or Validation in a regulated environment
• Exposure to validation, stability, or technical QA activities
• Strong data handling and report-writing capability
• Comfortable coordinating cross-functional technical work
• Methodical, organised and confident working with complex datasets
• Experience with validation or statistical software is beneficial but not essential.