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QA Officer – Validation & Compliance

Smart4Sciences · Widnes

🇬🇧 English
Analytical method validation Process validation Change Control CAPA Deviations OOS investigations Technology transfer

Job description

About the role

Smart4Sciences is partnering with a leading pharmaceutical company to hire a QA Officer focused on validation and compliance. Working in a GMP‑regulated environment, you will ensure that third‑party manufacturers and laboratories meet regulatory standards while supporting new product projects and ongoing quality initiatives.

Key responsibilities

  • Support new product development, technology transfers and introductions from a Quality Assurance perspective.
  • Coordinate and participate in project meetings with internal stakeholders and external manufacturing and testing partners.
  • Review and approve analytical method validation, verification and transfer protocols and reports.
  • Review manufacturing and packaging process validation protocols and reports.
  • Assess Master Batch Manufacturing and Packaging Records, product specifications, methods of analysis, shelf‑life and stability protocols.
  • Evaluate technical documentation from Contract Manufacturing Organisations and Contract Testing Laboratories.
  • Assess Quality Management System documentation, including Change Controls, Deviations, OOS investigations and CAPAs.
  • Maintain and update the Validation Master Plan to ensure ongoing compliance.
  • Support investigations, market complaints, SOP updates and continuous improvement activities.
  • Contribute to site KPIs, product quality objectives and HSE standards.

Required profile

  • Experience within pharmaceutical Quality Assurance in a GMP‑regulated environment.
  • Knowledge of validation principles, including analytical method and process validation.
  • Proven ability to review validation documentation, batch records and technical reports.
  • Strong understanding of Change Control, CAPA, Deviations and OOS investigations.
  • Familiarity with technology transfer and new product introduction activities is advantageous.
  • Excellent attention to detail and strong document review skills.
  • Effective communication and stakeholder management abilities.

Required skills

  • Analytical method validation
  • Process validation
  • Review of validation documentation, batch records and technical reports
  • Change Control, CAPA, Deviations and OOS investigations
  • Technology transfer and new product introduction

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Published 2 months ago

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Smart4Sciences

Widnes