Shape quality standards worldwide-be the voice of compliance.
Proclinical is seeking a Senior GMP Quality Auditor to join a team in the UK. This role focuses on managing vendor and supplier quality assurance processes in alignment with industry regulations and guidelines. You will work cross-functionally with supply chain, regulatory, and quality teams to ensure compliance and business alignment. The position involves national and international travel and offers the opportunity to mentor team members while contributing to the lifecycle management of approved vendors and suppliers.
Responsibilities:
1. Mentor team members and support their professional development.
2. Oversee the lifecycle management of approved vendors and suppliers in compliance with industry regulations.
3. Establish and monitor KPIs, evaluating and reporting associated metrics.
4. Manage a risk-based audit program for vendors and suppliers, excluding pharmacovigilance partners.
5. Conduct risk analysis based on audit outcomes and collaborate with QPs and management on necessary actions.
6. Ensure audits provide assurance for vendors and suppliers in line with EU GMP, EU GDP, or equivalent standards and marketing authorizations.
7. Monitor and maintain CAPAs internally and with external suppliers.
8. Maintain vendor validity within the SAP ERP system.
9. Evaluate and interpret global regulations for audit purposes.
10. Create, revise, and review QA documentation, including audit checklists, questionnaires, SOPs, and guidance documents.
11. Deputize for the Audit Manager as required.
Key Skills and Requirements:
12. Degree in Chemistry, Pharmacy, Microbiology, or equivalent.
13. General auditing qualification: external lead auditing qualification is desirable.
14. Proven experience in a similar role within the pharmaceutical industry.
15. Familiarity with directives and guidelines for medical devices, sterile manufacturing facilities, and biosimilars.
16. Strong organizational and time management skills with the ability to prioritize multiple tasks.
17. Excellent communication skills, both written and verbal, including the ability to engage with senior management at third-party suppliers.
18. Sound problem-solving skills and the ability to make decisions based on risk.
19. Willingness and ability to travel globally.
20. Proficient in working independently and collaboratively as part of a team.