Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The Role
The QA Officer QMS, is responsible for assisting the QMS Team in ensuring QMS related tasks are completed within the required timescales and in compliance with regulatory requirements.
Main responsibilities:
1. Produce compliance related metrics for the site and assist in the provision of data for
2. Quality Management Reviews.
3. Perform periodic updates of the Self-Inspection Schedule to ensure this is up to date.
4. Management and administration of Customer Complaints.
5. Track corrective and preventative actions from Internal and External audits.
6. Maintain and update the Approved Supplier List.
7. Perform vendor re-assessments.
8. Coordinate external audits in accordance with the required schedule.
9. Ensure Quality Agreements and TSE Statements are periodically updated within the
10. required timeframes.
11. Assist in the generation of Nitrosamines Statements.
12. Authoring of Product Quality Reviews.
13. Provide assistance during inspection readiness preparations e.g. completing SIPOC.
Requirements
14. Experience of working within a pharmaceutical environment under GMP.
15. GMP Skill Level 1 is essential for this role.
16. Proficiency in IT.
17. Previous experience within a Quality department is desirable, ideally within a cGMP/pharma
18. environment is desirable
19. Equivalent pharma industry experience.
20. Self-motivated
21. Ability to get results through co-operation and influence.
Benefits
At PCI, 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. Here's what we offer:
22. Employer Pension: Secure your future with our employer pension scheme (above statutory pension).
23. Competitive Salaries: We offer competitive salaries that reflect your dedication and contributions.
24. Generous Annual Leave: Enjoy 25 days of annual leave, plus bank holidays.
25. Family Friendly Benefits: Enjoy a range of benefits designed to support your family life.
26. Employee Referral Scheme: Know someone perfect for our team? Refer them and receive £500 as our way of saying thank you!
27. Staff Engagement: We value your dedication with recognition schemes and long-service awards.
28. Health and Well-being: Your health matters. Count on our support with generous sick pay, access to a 24/7 GP through our employee assistance program, mental health support, and life assurance up to 4 times your annual salary.
29. On-Site Subsidized Canteen.
30. Cycle to Work Scheme.
31. Development Opportunities: Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options.
#LI-AT1
Join us and be part of building the bridge between life changing therapies and patients.