Quality Assurance Manager
3 weeks ago
Company Overview
At PCI Pharma Services, we are dedicated to making a difference in the lives of patients by delivering innovative and high-quality pharmaceutical solutions.
We are seeking an experienced Quality Assurance Manager to join our team and play a key role in ensuring the excellence and regulatory compliance of our products.
Salary and Benefits
The salary for this position is estimated to be around £55,000 - £65,000 per annum, depending on experience. In addition to a competitive salary, we offer a range of benefits, including:
- A generous employer pension scheme
- Competitive annual leave package
- Family-friendly benefits
- Employee referral scheme
- Staff engagement programs
- Health and well-being initiatives
- Development opportunities
Job Description
This is a key player role in ensuring excellence and regulatory compliance, providing vital technical quality support for both new and ongoing projects. The successful candidate will interpret and apply business and regulatory guidelines, review and approve deviations and change controls, and address non-compliance issues.
Main Responsibilities
- To provide technical Quality support to the Operational departments for new and ongoing projects.
- Play a lead role in the interpretation of business and regulatory (EU/US/Japan) guidelines which assists with regulatory compliance.
- To promote a sense of quality throughout the site business units so as to raise manufacturing/ development/clinical performance and eliminate waste caused by unnecessary compliance errors.
- To conduct performance audits and follow up on actions within site business units.
- Review and approve, for all areas, Master Batch Records (MBR), master despatch job cards, Technical specifications and addendums, master label approvals, returned Technical Specifications and Technical Agreements.
- Write and review Drug Product Files (DPFs), Product Specification Files (PSFs)
- QA approval of Item Masters.
- Batch record compilation and regulatory checks.
- Interpret PQR data.
- Review and approve Deviations and Change Controls as needed.
- To review non-compliance identified by audit, deviations and complaints, and use technical / professional judgment to make the appropriate product quality decisions (in association with site QP's), and to initiate and promote quality improvements to prevent re-occurrence.
- To ensure that products proposed for release by a site QP were manufactured in accordance with license requirements, clinical trial application and cGMP.
- To assist with GMP training within the department and cross site.
Why Join Us?
At PCI Pharma Services, we believe that our employees are our most valuable asset. That's why we are committed to providing a benefits package designed to support your well-being and enhance your overall quality of life.
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