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QA Regulatory Compliance Specialist, Stamullen
Client: PCI Pharma Services
Location: Stamullen
Job Category: Other
EU work permit required: Yes
Job Reference: 975625adac4c
Job Views: 5
Posted: 19.06.2025
Expiry Date: 03.08.2025
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 related to the introduction and maintenance of third-party/clinical products within the PCI Quality Assurance department. Role supports right first time QP release and clients in management and oversight of regulatory changes.
Main responsibilities:
* 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 (Commercial).
* 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 third-party/clinical supply chains at PCI, including preparation and maintenance of approved products and supplier lists.
* Maintenance of Approved CMO list for Clinical and Commercial Supply Chain.
* Maintenance of Supply Chain/CMO Risk Register, highlighting sites that need support or remediation.
* Support for new project setup, regulatory compliance, and client support regarding EU/UK regulations.
* Ensure ongoing compliance with customer, regulatory, and internal requirements.
* Manage Supplier Management Programme, including audits, quality agreements, qualification, and vendor performance reviews.
* Prepare and review Quality documents (QP Declarations, QP to QP, QTA) for approval.
* Review and track change controls with product quality or regulatory impact.
* Support management of manufacturing and importation licenses and variations.
* Raise Deviations, CAPAs, and Non-Conformance reports, ensuring communication to management.
* Generate SOPs, forms, job aids, and work instructions.
* Identify and support process and procedure improvements.
* Manage specific or ad hoc projects as needed.
Join us and be part of building the bridge between life-changing therapies and patients.
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