AssureBio, based in Greater London, England, United Kingdom, is partnering with a UK‑based pharmaceutical manufacturer to appoint a QA Validation Coordinator in 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. Your work will directly support QA and inspection readiness.
Responsibilities
- Owner and maintain the Validation Master Plan (VMP) and key validation frameworks.
- Coordinate process, cleaning, analytical method, stability, and hold‑time validation activities.
- Support continuous process verification (CPV) and periodic re‑validation reviews.
- Manage validation inputs into Annual Product Quality Reviews (APQRs).
- Ensure validation work reflects routine manufacturing and packaging batches.
- Support new product introduction and technical change activities.
- Raise and support deviations linked to validation or GMP issues.
Key Experience
- 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.
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).
Job Details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing
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