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This job expired on 27/09/2026. It no longer accepts applications.
QA Officer – Validation & Compliance
Smart4Sciences · Widnes
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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Smart4Sciences
Widnes
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