Senior Quality Assurance Officer
3 weeks ago
Company: Nicholas Associates Group Limited
Job Type: Permanent
Location: Birmingham
Working Days: Monday to Friday
Nicholas Associates Group Limited, a UK leader in the pharmaceutical industry, is seeking a permanent Senior Quality Assurance Officer to spearhead their GMP journey.
- This role will support all ongoing quality initiatives and activities in line with MHRA requirements and expectations.
- This is a critical position within our client's business to ensure compliance with regulatory standards.
- To monitor and report to the management group compliance against the key aspects of the Quality Management System.
- Manage the Quality Management System, including deviations, CAPA, change control, and standard operating procedures (SOPs).
- Provide technical support as required in relation to customer enquiries and supporting any associated customer complaint investigations.
- To investigate product complaints and generate investigation reports.
- Act as a key person for pharmacovigilance queries in the absence of the Quality Manager.
- Assist in the coordination and performance of internal quality audits as required.
- Deputise for the Quality Manager as and when required, i.e. attending meetings in their absence.
- Lead the review, approval, and release of SOPs, Instructions, Forms, Batch Production Records, and testing data.
- Coach and mentor team members on quality assurance and business requirements, including best practices.
- Proven experience in a Quality driven role in Pharmaceuticals with a good understanding of the UK regulatory market, including GMP, GACP, and GDP.
- Experience of managing a quality team is highly desirable.
- Degree (or equivalent) in a Scientific discipline.
- Good understanding of good agriculture and collection practices.
- Proficient in MS Office.
- Always looking to improve QMS performance.
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