Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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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.
Role Summary
The QA Specialist QMS is responsible for supporting and maintaining the Quality Management System at PCI Tredegar.
This fully on-site role requires strong technical and regulatory knowledge, attention to detail, and a commitment to quality and continuous improvement. The job holder will work largely independently under the supervision of the QMS Manager, providing guidance, training, and support across the site while upholding PCI’s values and regulatory standards.
Main Responsibilities
1. The QA Specialist coordinates and completes external vendor audits according to an agreed programme, ensuring compliance with PCI procedures, risk assessments, and cost-effectiveness. They manage, administer, and approve customer complaint investigations, ensuring thorough assessment and documentation of issues.
2. Tracking corrective and preventative actions from internal and external audits is a key responsibility, including closing actions where possible or supporting other departments to achieve closure. The role requires regular use of the PCI Tredegar quality system software, Master Control, to manage corrective and preventative actions, client audits, and supplier assessments.
3. The QA Specialist maintains and updates the Approved Supplier List and reports relevant Key Performance Indicators. Compliance with company policies, procedures, and internal/external Health, Safety, and Environmental standards is mandatory.
4. The role involves undertaking projects within the job holder’s capabilities, proactively identifying opportunities for continuous improvement, and reviewing and improving departmental processes to eliminate waste. Conducting GxP training and contributing to training materials is also part of the role, alongside ensuring timely review and approval of quality documentation.
5. The job holder collates Quality Management Review (QMR) information for senior management, applies Quality Risk Management principles, investigates deviations, errors, failures, and adverse events, and uses professional judgement to support product quality decisions in collaboration with site Qualified Persons.
6. Additional responsibilities include reviewing and approving extensions and justifications, managing the Product Quality Review (PQR) schedule, hosting internal meetings, facilitating PPS meetings, completing customer questionnaires, and updating policies and procedures. The role also requires identifying personal development needs to support future growth.
Requirements
7. Experience in a similar pharmaceutical role is required, with credentials covering both investigational and marketed products.
8. Strong interpersonal and communication skills, a commitment to continuous improvement, effective planning, and the ability to manage multiple tasks simultaneously are essential.
9. A completion-driven mindset with attention to detail, experience in vendor management.
10. Desirable experience in risk management and PQR completion are important for success in this role.
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:
11. Employer Pension: Secure your future with our employer pension scheme (above statutory pension).
12. Competitive Salaries: We offer competitive salaries that reflect your dedication and contributions.
13. Generous Annual Leave: Enjoy 25 days of annual leave, plus bank holidays.
14. Family Friendly Benefits: Enjoy a range of benefits designed to support your family life.
15. Employee Referral Scheme: Know someone perfect for our team? Refer them and receive £500 as our way of saying thank you!
16. Staff Engagement: We value your dedication with recognition schemes and long-service awards.
17. 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.
18. On-Site Subsidized Canteen.
19. Cycle to Work Scheme.
20. Development Opportunities: Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options.
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Join us and be part of building the bridge between life changing therapies and patients.