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Permanent

QA Officer

Widnes
money-bag Negotiable
225414621
Posted Yesterday

QA Officer



About the Role

Smart4 Sciences is partnering with a leading pharmaceutical company to recruit a QA Officer - Validation & Compliance. This is an excellent opportunity for someone with experience in pharmaceutical Quality Assurance who enjoys working across validation, compliance, technology transfer, and new product introduction activities.

Working within a GMP-regulated environment, you will play a key role in ensuring third-party manufacturers and laboratories remain compliant with regulatory requirements and registered dossiers while supporting the successful delivery of new product projects and ongoing quality initiatives.



Key Responsibilities

  • Support new product development, technology transfers, and new product 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.

  • Review Master Batch Manufacturing and Packaging Records, finished product specifications, methods of analysis, shelf-life specifications, and stability protocols.

  • Evaluate technical documentation provided by Contract Manufacturing Organisations (CMOs) and Contract Testing Laboratories (CTLs).

  • Assess Quality Management System documentation including Change Controls, Deviations, Out of Specification (OOS) investigations, CAPAs, and associated quality records.

  • 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 Health, Safety & Environmental (HSE) standards.

  • Build strong working relationships with internal departments including Regulatory Affairs, Supply Chain, Logistics, and Sales, as well as external CMOs and CTLs.



About You

We''re looking for someone who has:

  • Experience within Pharmaceutical Quality Assurance in a GMP-regulated environment.

  • Knowledge of validation principles, including analytical method validation and process validation.

  • Experience reviewing validation documentation, batch records, technical reports, and quality documentation.

  • Good understanding of Change Control, CAPA, Deviations, OOS investigations, and Quality Management Systems.

  • Familiarity with technology transfer and new product introduction activities would be advantageous.

  • Excellent attention to detail with strong document review skills.

  • Strong communication and stakeholder management skills.

  • The ability to manage multiple priorities while meeting project deadlines.

  • A degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or a related scientific discipline is desirable.



What''s on Offer

  • Opportunity to work on exciting new product and technology transfer projects.

  • Exposure to cross-functional teams and external manufacturing partners.

  • Career development within a growing pharmaceutical quality function.

  • Supportive and collaborative working environment.

  • Competitive salary and benefits package.

If you''re passionate about pharmaceutical quality, validation, and compliance and want to play a key role in delivering high-quality products to market, we''d love to hear from you. Apply today!

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