Senior QA Officer North Merseyside Salary up to £40,000 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. You will have 2 direct reports. 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