QA Regulatory Compliance Specialist

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:

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. Commercial

Clinical Release

Oversight and approval of Products Specification File (PSF) for Clinical supply chain 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. / 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 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 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 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.

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (https://pci.com/)

PCI Pharma Services QA Regulatory Compliance Specialist in Bridgend, United Kingdom

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., PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled