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.
Main purpose of job:
The role is to implement and execute tasks relating to the introduction and maintenance of third party/clinical products within the third party/clinical Quality Assurance department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
Main responsibilities:
Commercial Release
1. Creation and maintenance of Drug Product File (DPF) for commercial supply chain where QP certification is performed
2. Preparation and review of product quality reviews for third party QP release. Commercial
Clinical Release
3. Oversight and approval of Products Specification File (PSF) for Clinical supply chain where QP certification is performed.
All
4. Developing and managing Quality Systems & Compliance to support the maintenance and release of third party/clinical supply chains at PCI. / Preparation and maintenance of the third party/clinical approved products and supplier lists.
5. Maintenance of Approved CMO list for Clinical and Commercial Supply Chain
6. Maintenance of Supply Chain/CMO Risk Register, highlight at risk sites that need additional support or remediation.
7. Attend on going set up for new projects and provide quality support and awareness of EU/UK regulations to clients support clients in management of regulatory changes
8. Ensure on-going compliance and support with customer, regulatory and internal requirements.
9. Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers. – supply chain sites of interest
10. Request, manage, preparation of Quality documents (QP Declarations, QP to QP, QTA) for review and approval by third party QP/ third party quality contacts at PCI
11. Review and track third party change controls which have a product quality or regulatory impact / support wider implications
12. Support the management of the Manufacturing and Importation License held by regional site PCI entity and the associated variations to it.
13. Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
14. Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
15. Identify and support opportunities for improving processes and or procedures.
16. To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.
Join us and be part of building the bridge between life changing therapies and patients.