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QA Regulatory Compliance Specialist, Stamullen
Client: PCI Pharma Services
Location:
Job Category: Other
EU work permit required: Yes
Job Reference: 975625adac4c
Job Views: 2
Posted: 02.04.2025
Expiry Date: 17.05.2025
Job Description:
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:
1. Commercial Release:
* Creation and maintenance of Drug Product File (DPF) for commercial supply chain where QP certification is performed.
* Preparation and review of product quality reviews for third party QP release.
1. Clinical Release:
* Oversight and approval of Products Specification File (PSF) for Clinical supply chain where QP certification is performed.
2. All:
* 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.
* Maintenance of Approved CMO list for Clinical and Commercial Supply Chain.
* Maintenance of Supply Chain/CMO Risk Register, highlight at risk sites that need additional support or remediation.
* Attend ongoing setup for new projects and provide quality support and awareness of EU/UK regulations to clients.
* Ensure on-going compliance and support with customer, regulatory and internal requirements.
* Management and coordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification, and vendor performance for third party suppliers.
* Request, manage, and prepare 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 the management of the Manufacturing and Importation License 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 Instructions 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.
Join us and be part of building the bridge between life changing therapies and patients.
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