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Regulatory Compliance Specialist

2 months ago

Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time
Main Purpose

The role is to implement and execute tasks related to the introduction and maintenance of third-party/clinical products within the Quality Assurance department at PCI Pharma Services.

Main Responsibilities
  • Commercial Release
    • Creation and maintenance of Drug Product Files (DPFs) for commercial supply chains where QP certification is performed.
    • Preparation and review of product quality reviews for third-party QP release.
  • Clinical Release
    • Oversight and approval of Product Specification Files (PSFs) for clinical supply chains where QP certification is performed.
  • All
    • Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party/clinical supply chains at PCI Pharma Services.
    • Maintenance of Approved CMO lists for Clinical and Commercial Supply Chains.
    • Maintenance of Supply Chain/CMO Risk Registers, highlighting at-risk sites that need additional support or remediation.
    • Attending ongoing setup for new projects and providing quality support and awareness of EU/UK regulations to clients.
    • Ensuring ongoing compliance and support with customer, regulatory, and internal requirements.
    • Management and coordination of Supplier Management Programs, including supplier audits, quality technical agreements, supplier qualification, and vendor performance for third-party suppliers.
    • Requesting, managing, and preparing Quality documents (QP Declarations, QP to QP, QTA) for review and approval by third-party QP/third-party quality contacts at PCI Pharma Services.
    • Reviewing and tracking third-party change controls with product quality or regulatory impact.
    • Supporting the management of Manufacturing and Importation Licenses held by regional PCI entities and associated variations.
    • Raising Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner.
    • Generating SOPs, Forms, Job Aids, and Work Instructions on the Master Control system.
    • Identifying and supporting opportunities for improving processes and procedures.
    About PCI Pharma Services

We are a global company that bridges life-changing therapies and patients. Our investment is in people who make an impact, drive progress, and create a better tomorrow.