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 responsibilities:

• Oversight and approval of Products Specification File (PSF) for Clinical supply chain where QP certification is performed.
• Developing and managing Quality Systems & Compliance to support the maintenance and release of clinical supply chains at PCI. Preparation and maintenance of the clinical approved products and supplier lists.
• Maintenance of Supply Chain/CMO Risk Register, highlight at risk sites that need additional support or remediation.
• 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
• Ensure on-going compliance and support with customer, regulatory and internal requirements.
• 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
• 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
• Review and track third party change controls which have a product quality or regulatory impact / support wider implications
• Support the management of the Manufacturing and Importation Licence held by regional site PCI entity and the associated variations to it.
• Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
• Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
• Identify and support opportunities for improving processes and or procedures.
• 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.