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Head of Quality
2 months ago
Exciting opportunity: Head of Quality/ Qualified Person for a growing pharmaceutical manufacturer.
If you are a seasoned Quality professional, based in or around St Albans, Hertfordshire, with leadership experience in the pharmaceutical industry, this role might be for you This role will be on-site 5 days per week.
Your Responsibilities:
- Responsible to oversee and continually review the quality management system to ensure that improvements are identified and that any deficiencies are addressed at their root cause and appropriate procedures are developed and fully implemented.
- Verify and ensure that the products are manufactured, packed and tested to the requirements of registered MA.
- Responsible to review the third-party audit reports for APIs and packaging materials. Responsible for the review of annual product quality reviews.
- Ensuring complaints and adverse incidents are accurately recorded and addressed in a thorough and timely manner in accordance with the company QMS.
- Responsible for hosting MHRA inspections, writing the response reports and to liaise with the Medicines Inspectorate to ensure that the Company conforms to the requirements of GMP and the Manufacturing and Product Licenses.
- Develop, manage and maintain the company's device family technical files and product specific design dossiers ensuring compliance with the relevant regulations.
- Remain up to date with impending changes and developments regarding regulatory and compliance requirements as well as evolving best practices in compliance control.
- To approve specifications, sampling instructions, test methods, and QC procedures, including amendments.
- To approve and monitor suppliers of raw materials and packaging components.
Additional responsibilities for Head of Quality as QP:
- Responsible as named QP to coordinate the preparation and hosting of MHRA and customer inspections.
- To act as 'Qualified Person' in approving Finished Product for release onto the marketplace.
- Performing QP batch certification of licensed medicines (per applicable regulations) and providing QP support as required for Quality issues.
Your experince, skills and qualifications:
- A bachelors or associate degree.
- A minimum of 5 years experince in the Quality Assurance at a manufacturing site
- Previous experince in a leadership role.
- Extensive Pharmaceutical Industry experince with hands on experince in development/quality in a GxP environment.
If this sounds like the perfect opportunity for you or someone you know, please share your CV at e.smailes@x4lifesciences.com
