QA Regulatory Compliance Specialist

at  PCI Pharma Services

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 responsibilities:

• 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 clinical supply chains at PCI. Preparation and maintenance of the clinical approved products and supplier lists.
• 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 Licence 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
Equal Employment Opportunity (EEO) Statement:
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

• 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 clinical supply chains at PCI. Preparation and maintenance of the clinical approved products and supplier lists.
• 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 Licence 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