About the Role
A leading pharmaceutical development and manufacturing organisation is seeking a QA Compliance Officer to support the governance and compliance of its Pharmaceutical Quality Management System (PQS). This role plays a key part in maintaining regulatory compliance across international standards including UK/EU/US GMP/GDP and ICH guidelines.
Key Responsibilities
1. Support quality system elements such as QMS monitoring, supplier qualification, and audits.
2. Assist in maintaining and updating regulatory registrations, licences, and certifications.
3. Track site compliance commitments and regulatory trends.
4. Collaborate with site functions to reduce compliance issues and implement improvements.
5. Review QMS documentation in line with global regulatory guidance.
6. Lead Quality Management Review meetings.
7. Support investigations and develop effective CAPA.
8. Prepare for regulatory and customer audits and support follow-up.
9. Escalate significant compliance concerns to Quality Management.
10. Build strong working relationships with stakeholders.
Essential Qualifications & Experience
11. Degree or relevant qualification in a scientific, business, or engineering discipline.
12. Minimum 2 years' experience in QA within a GMP environment.
13. Experience conducting internal or supplier audits.
14. Experience with QMS documentation (SOPs, deviations, investigations, CAPA).
Desirable Experience
15. Certified Auditor training.
16. Supplier/vendor/material approval experience.
17. Experience supporting regulatory audits.
Key Competencies
18. Strong attention to detail
19. Problem-solving skills
20. Excellent communication
21. Proficiency in Microsoft Office applications
What is on Offer
22. Excellent benefits package including enhanced pension, healthcare and bonus scheme.
23. Development and learning opportunities.
Guidant,