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Full Job Description
An exciting opportunity to work for a mid-sized global pharmaceutical company that is recruiting for a Supplier Assurance Specialist to join their Global Product Quality team based in Berkshire.
Please note that this role is more of a junior position.
We are seeking a high-performing individual with around 2 years of experience in supplier audit, compliance, and familiarity with GMP/GDP and management systems.
Our client offers an excellent environment for individuals to be part of high-performing, passionate teams, with opportunities to progress and develop new skills. The company is also experiencing growth with new products launching over the next 24 months.
Hybrid working involves 2 days per week in the office.
Responsibilities include:
1. Contributing to the management and maintenance of quality systems to ensure full compliance with relevant legislation and industry best practices.
2. Supporting the management of suppliers and service providers across manufacturing, automated packaging, and distribution activities throughout Europe.
3. Maintaining an audit schedule of contractors and suppliers based on risk assessments and qualification processes.
4. Performing GxP audits at partner sites, mainly within Europe.
5. Following up on audit reports and ensuring corrective and preventative actions are implemented effectively.
6. Contributing to the development and improvement of supplier management policies, standards, and procedures.
7. Participating in supplier development projects and continuous improvement activities focusing on supplier quality.
8. Assisting with internal audits and regulatory inspections.
9. Maintaining the Approved Supplier List and assessing areas during evaluations.
10. Tracking supplier quality metrics, identifying non-conformance trends, and implementing appropriate actions.
11. Leveraging best practices across supplier qualification, surveillance, and quality management systems.
12. Contributing to the development and maintenance of GMP and GDP compliant quality systems.
13. Preparing GMP documentation such as SOPs and Quality Technical Agreements.
14. Collaborating with suppliers on process development, agreement, and documentation.
15. Managing supplier-related changes and ensuring compliance with product licenses and submissions.
16. Liaising with suppliers regarding returned or defective products.
17. Gathering and analyzing data for periodic product quality reviews and reports.
18. Proactively identifying issues and seeking resolutions.
19. Applying experience in GMP/GDP Quality Management Systems and additional QA areas.
20. Learning and adapting quickly to evolving requirements.
21. Working effectively under tight deadlines.
22. Handling sensitive and confidential information appropriately.
23. Negotiating with third parties regarding quality processes.
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