|Job title :||Qualified Person (QP)|
|Job type :||Permanent|
|Salary :||£75000 - £86000 per annum + bonus, private health care|
|Contact name :||Cameron Simpson|
|Contact email :||firstname.lastname@example.org|
My client, is a global pharmaceutical company based in the Manchester area, and are currently looking for an experienced Quality Assurance Manager - Qualified Person (QP).
Your responsibilities: 1. Represent Quality functions with strong strategic focus, regulatory awareness and quality expertise. 2. Manage the maintenance of quality systems according to the required SOP and regulations 3. Ensure compliance of calibration and qualification of all equipment and computerized systems incl. review and approval. 4. Communicate to Head of development QA about any potential quality issues in a timely manner 4. Take responsibility for quality systems investigations, deviations and CAPAs including follow-up activities. 5. Take responsibility for Change Control within the department throughout all development phases up to pre-submission. Carry joint responsibility with TechOps QA after submission. 6. Perform Self-Inspections, and act as a point of contact to authority audits. 7. Prepare follow-up responses and monitor CAPAs. Manage compliance and request supplier and third party audits.
All applicants must have a bachelors degree in a life science subject or relevant discipline, along with possessing expert knowledge of GxP regulations with broad experience in GMP. Management experience, particularly cross-departmental is advantageous.
Interviews have been set, and all applications will be reviewed.