QA Operations Lead – Pharmaceuticals, GMP
Are you looking to further develop your career in a fast-paced and growing environment? Next Phase are supporting a global leading CMO in the Birkenhead area in their search for a QA Operations Lead. This is a full time, permanent position which requires the individual to be on-site.
About the role :
Make sure that the team are consistently creating top-notch documentation to keep the site running smoothly. This includes works orders, specifications, bills of materials, and release certificates. Keep a tight grip on all product specifications, and make necessary changes known. You will be providing quality support in manufacturing, packaging operations, warehouse and other areas of the business
Manage QA Operations Team workload for right-first-time manufacturing, testing, reporting, and product release. Prioritize tasks with QPs to meet agreed lead times.
Oversee quality approval of materials, bulk products, and components. Conduct sampling, testing, and approval for on-time product delivery. Coordinate with contract laboratories and maintain a sample retention system.
Lead Supplier Assurance Programme, including scheduling supplier audits, qualification/re-qualification, and handling non-conformances. Communicate with suppliers on quality issues, conduct investigations, and support issue resolution.
Review batch documentation and ancillary documents for non-medicinal product release. Support Qualified Persons in reviewing documents for medicinal finished product disposition. Ensure batch release complies with ISO13485, EU GMP, MA, National Law, and Annex-16 guidelines.
Support new product introduction with a collaborative approach to meet targets.
Location : Birkenhead
Salary : Competitive
Full time, on-site, permanent position