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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 providing data for Quality Management Reviews.
2. Perform periodic updates of the Self-Inspection Schedule to ensure it is up to date.
3. Manage and administer Customer Complaints.
4. Track corrective and preventative actions from Internal and External audits.
5. Maintain and update the Approved Supplier List.
6. Coordinate external audits according to the required schedule.
7. Ensure Quality Agreements and TSE Statements are periodically updated within the required timeframes.
8. Assist in the generation of Nitrosamines Statements.
9. Author Product Quality Reviews.
Requirements
* Experience working within a pharmaceutical environment under GMP.
* GMP Skill Level 1 is essential.
* Proficiency in IT.
* Previous experience within a Quality department is desirable, ideally within a cGMP/pharma environment.
* Equivalent pharma industry experience.
* Self-motivated with the ability to achieve results through cooperation and influence.
At PCI, we believe that our employees are our most valuable asset. We are committed to providing a benefits package to support your well-being and enhance your overall quality of life. Our offerings include:
* Employer Pension: Secure your future with our employer pension scheme (above statutory pension).
* Competitive Salaries: Reflecting your dedication and contributions.
* Generous Annual Leave: 25 days plus bank holidays.
* Family-Friendly Benefits: Supporting your family life.
* Employee Referral Scheme: Refer someone perfect for our team and receive £500.
* Staff Engagement: Recognition schemes and long-service awards.
* Health and Well-being: Sick pay, 24/7 GP access, mental health support, and life assurance up to 4 times salary.
* Cycle to Work Scheme.
* Development Opportunities: Training programs, coaching, LinkedIn Learning, and further education.
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Join us and help build the bridge between life-changing therapies and patients.
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