Validation Coordinator
AssureBio - norwich, east anglia
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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.ResponsibilitiesAs 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 frameworksCoordinating process, cleaning, analytical method, stability and hold-time validation activitiesSupporting continuous process verification (CPV) and periodic re-validation reviewsManaging validation inputs into Annual Product Quality Reviews (APQRs)Ensuring validation work reflects routine manufacturing and packaging batchesSupporting new product introduction and technical change activitiesRaising and supporting deviations linked to validation or GMP issuesTechnical Focus AreasManufacturing & packaging process assessment (e.g. blending, granulation, compression, coating, packaging)Cleaning validation and contamination control strategiesAnalytical method validation (non-pharmacopoeial where required)Stability study coordination, reporting and trendingStatistical analysis and data review (e.g. CpK, trending, datasets)Key ExperienceLife science degree (or equivalent scientific background)Experience across QC, QA, Manufacturing or Validation in a regulated environmentExposure to validation, stability, or technical QA activitiesStrong data handling and report-writing capabilityComfortable coordinating cross-functional technical workMethodical, organised and confident working with complex datasetsExperience with validation or statistical software is beneficial but not essential.
Created: 2026-01-18