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