QA Manager and Qualified Person

2 months ago


East Midlands, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

Walker Cole International are searching for a Quality Assurance Manager and Qualified Person to join a well-established international pharmaceutical business in the Midlands. As a QA Manager and QP you will be a key part of managing the business' qualityfunctions and performing routine batch release activities.

You will be responsible for:

- Developing, maintaining and improving the QMS and Compliance strategy to reflect cGMP regulations and regulatory standards.
- Training and developing members of the quality team as well as managing team goals and performance.
- Ensure all manufacturing, testing and release activities are carried out in accordance with cGxP standards.
- Carry out Qualified Persons responsibilities of both IMP and Commercial products.
- Qualified Person (QP) qualification under the provision of the UK Statutory Instruments 2012/1916 and 2004/1031.
- Experience with both Investigational Medicinal Products and Commercial products.
- Strong knowledge of cGMP, MHRA, FDA and EU guidelines.
- Strong leadership, communication and organisational skills.

Quality Assurance | QA | Qualified Person | Pharmaceutical | CAPA | Corrective and Preventative Action | Quality | eQMS | PQS | Pharmaceutical Quality System | Batch Release | QP | GMP | Good Manufacturing Practice | QMS | Quality Management System | Operational| IMP | Investigational Medicinal Product | Commercial | GCP


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