QA Regulatory Compliance Specialist

Get AI-powered advice on this job and more exclusive features. 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. Job Description

• Creation and maintenance of Drug Product File (DPF) for commercial supply chain where QP certification is performed.
• Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
• Maintenance of Approved CMO list for Commercial Supply Chain.
• Maintenance of Supply Chain/CMO Risk Register, highlight at risk sites that need additional support or remediation.
• Ensure ongoing compliance with customer, regulatory and internal requirements.
• Management and coordination of Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third-party suppliers.
• Preparation and maintenance of the third party/clinical approved products and supplier lists.
• Preparation of QP declarations for review and approval by third party QP at PCI.
• Preparation and review of product quality reviews for third party QP release.
• Review and track third party change controls which have a product quality or regulatory impact.
• Support the management of the Manufacturing and Importation Licence held by Millmount 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 Instructions on the Master Control system.
• Identify and support opportunities for improving processes and/or procedures.
• Undertake such tasks and manage specific or ad hoc projects as required to meet department and business needs within the scope of the job-holder’s capabilities.

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