Senior QA Officer

Nexus Life Sciences; Knowsley; On-site; GBP 34,000 - 40,000; Full time

Job summary

A pharmaceutical manufacturer in North Merseyside is seeking a Senior Quality Assurance Officer to enhance their Quality Management System and ensure GMP compliance. This role involves overseeing audits, product release, and managing investigations. The ideal candidate will have a Bachelor's degree in a scientific field and 4-6+ years of experience in a regulated environment. Strong knowledge of FDA/EMA regulations and experience with QMS software is essential. This is an excellent opportunity to join a respected company.

Qualifications

• Proven experience in a regulated pharmaceutical/biologics environment (GMP/GDP).
• Strong understanding of FDA/EMA regulations and guidelines.
• Minimum of 4-6+ years' GMP experience.

Responsibilities

• Maintain and improve the Quality Management System.
• Ensure adherence to GxP regulations and support audits.
• Oversee batch release processes.

Skills

Leadership

Communication

Problem Solving

Root Cause Analysis

Education

Bachelor's degree in a scientific field

Tools

TrackWise

SAP

Job description

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!

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