QA Regulatory Compliance Specialist

PCI is looking for a QA Regulatory Compliance Specialist to implement and execute tasks related to the introduction and maintenance of third party/clinical products within the clinical regulatory compliance department.

Requirements

• Creation and maintenance of Products Specification File (PSF) for Clinical supply chain
• Developing and managing Quality Systems & Compliance to support the maintenance and release of clinical supply chains at PCI
• Maintenance of Approved CMO list for Clinical Supply Chain
• Maintenance of Supply Chain/CMO Risk Register, highlight at risk sites that need additional support or remediation
• Ensure on-going compliance with customer, regulatory and internal requirements
• Management and co-ordination 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 License 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 Instruction's on the Master Control system
• Identify and support opportunities for improving processes and or procedures
• Undertake tasks and 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

Benefits

• Equal Employment Opportunity (EEO) Statement
• Commitment to Equity and Inclusion