Senior QA Officer CV-Library Senior QA Officer

Scienceabode; England; On-site; GBP 33,000 - 40,000; Full time

Job summary

An established pharmaceutical manufacturer in the United Kingdom is seeking a Senior QA Officer to enhance their Quality Management System and ensure compliance with GMP regulations. The ideal candidate has a Bachelor's degree in a scientific field and at least 4–6 years of experience in a regulated environment. Responsibilities include managing the QMS, ensuring product compliance, and leading quality investigations. The salary is up to £40,000 per annum.

Qualifications

• Proven experience in a regulated pharmaceutical/biologics environment (GMP/GDP).
• Strong understanding of FDA/EMA regulations and guidelines.
• At least 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 for products.

Skills

Leadership

Communication (written/verbal)

Problem-solving

Education

Bachelor’s degree in a scientific field

Tools

QMS software (e.g., TrackWise, SAP)

Job description

Senior QA Officer – Cheshire – 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.

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.

£33,000 – £40,000/annum

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