Job Reference: J5630689
Updated On: 02/01/2019
Status: Now Interviewing
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Role OverviewWe are currently looking for a QA Manager to join a leading Therapeutics company based in the Hertfordshire area. As the QA Manager you will be responsible for managing the implementation and development of a GMP compliant Quality System.
Key Duties and ResponsibilitiesYour duties as the QA Manager will be varied however the key duties and responsibilities are as follows:
1. You will work cross functionally with the wider management team, participating in the commissioning and validation phases of the GMP facility ensuring the build and equipment are fit for purpose.
2. As the QA Manager, you will be tasked with the build and management of the Quality System, ensuring GMP compliance throughout. This will include developing SOP's, Monitoring Change Controls, Implementing CAPA to improve product quality, alongside reviewing Quality and Batch documentation.
3. Provide tactical support for the management of regulatory agency and client inspections, this may include acting as a site host during audits.
4. You will provide general subject expertise in Quality related issues with internal and external partners. This will include working with various regulatory agencies, including FDA & MHRA.
Role RequirementsTo be successful in your application to this exciting opportunity as the QA Team Leader we are looking to identify the following on your profile and past history:
1. Relevant degree in a life sciences discipline.
2. Proven industry experience in a GMP environment producing Phase III/commercial biologic's, vaccines, cell or gene therapies.
3. A working knowledge and practical experience with EU/ MHRA FDA regulations.
Key Words: Quality Manager | Quality Assurance | QA | Manager | FDA | MHRA | ATMP | Cell Therapy | Gene Therapy | GMP | Manufacturing | Biologics | Pharma
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