Summary: The Quality Specialist role involves ensuring compliance with GMP and regulatory standards within a biopharmaceutical company in London. The position requires the final review of clinical batch records and conducting audits of data and systems. This is a contract position for 6 months, focusing on maintaining high-quality standards in production and analytical documentation. Candidates must have relevant scientific qualifications and experience in a quality function within the pharmaceutical or chemical industries.

Key Responsibilities:

• Responsible for the final review of clinical batch records.
• Ensure compliance with GMP and conformance with regulatory filings.
• Conduct routine audits of data, information, procedures, equipment and systems.
• Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots.
• Perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards.

Key Skills:

• Hold a relevant scientific degree or have equivalent working experience.
• Previous working experience in a quality function, within either pharmaceutical or chemical industries.
• Excellent knowledge of cGMP regulations.
• Experience of participating in audits.

Salary (Rate): £28.33

City: London

Country: UK

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other