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Senior QA Officer

Cheshire

Competitive salary

A rare opportunity has arisen for a Senior Quality Assurance Officer to join my client, an established pharmaceutical manufacturer. This role plays a key part in maintaining and enhancing the Quality Management System and ensuring GMP compliance across manufacturing operations.

Key Responsibilities

* QMS Management: Maintain and improve the Quality Management System, handling change control, deviations, CAPAs, investigations, and documentation.

* Compliance & Audits: Ensure adherence to GxP (GMP, GDP, GCP) regulations, support internal/external audits, and act as a point of contact for regulatory bodies.

* Product Release: Oversee batch release processes, ensuring products are fit for purpose before sale or use.

* Investigations & CAPAs: Lead investigations (e.g., root cause analysis) for quality events like deviations, non-conformances, and complaints, and implement corrective/preventative actions.

* Documentation: Author, review, and approve controlled documents, quality records, and reports (KPIs).

* Supplier Management: Manage and monitor the supplier qualification program.

* Training & Support: Provide guidance and training to technical, production, and other teams on quality assurance issues.

Essential Skills & Qualifications

* Education: Bachelor's degree in a scientific field (Chemistry, Pharmacy, Biology).

* Experience: Proven experience in a regulated pharmaceutical/biologics environment (GMP/GDP).

* Regulatory Knowledge: Strong understanding of FDA/EMA regulations and guidelines.

* Technical Skills: Familiarity with QMS software (e.g., TrackWise, SAP).

* Soft Skills: Excellent leadership, communication (written/verbal), interpersonal, and problem-solving skills (Root Cause Analysis).

If you are an experienced QA Officer, with at least 4–6+ years’ GMP experience then please apply now!

Please note: Applicants must have the right to work in the UK. Sponsorship is not available for this role