Compliance Specialist - Cashel, Co Tipperary (12 month contract with a view to permanency)
Compliance Specialist Industry : Pharmaceutical Job Responsibilities: Co-ordinating the Complaints / Quality Defect Reporting Systems, including but not limited to the initiation of complaint /Quality Defect Reports (QDRs), consulting with relevant parties, leading/participating in investigations, agreeing appropriate CAPA etc. Identifying and communicating to Quality leadership issues that may impact product quality, safety, efficacy, regulatory compliance, or business continuity which have arisen from a supplier or other element of the role. Reviewing / leading Investigations / Root Cause Analysis / Quality Risk Management exercises to ensure any such investigations are documented appropriately with relevant CAPA, if necessary. Co-ordinating of local regulatory activities including update/ maintenance of the Site Master File, the company manufacturing authorisations, and other relevant documents. Co-ordinating of the Supplier Quality Management System, including conducting supplier audits, reviewing supplier documentation, generating / reviewing Quality Agreements, co-ordination of the supplier notification system, conducting periodic reviews of suppliers etc. Co-ordinating any site regulatory audit readiness programs, including managing the front room, collating audit responses, agreeing CAPA, etc. Supporting QP certification activities (i.e., batch record review, IMP Order authorisation, Product Specification File maintenance, etc.) Ensuring all QMS commitments are met by conducting the required actions, providing all necessary supporting documentation etc. Supporting the review and approval of Quality System /Compliance documents e.g., Deviations, Change Controls, CAPA, SOPs, Protocols, Reports etc. Co-ordinating and participating in the company self-inspection system, including conducting walkdowns /process /internal audits, authoring reports, consulting with stakeholders, agreeing appropriate CAPA, conducting trend analysis etc. To identify, develop, establish, implement, maintain, and continually improve quality processes, methodologies, systems, and practices to meet regulatory and corporate requirements. Generating /Updating Quality Procedures and other documents to ensure current best practices. Supporting New Project Introduction /Technology Transfer projects as required. Preparing Annual Product Quality review reports. Supporting the Quality Management Review process by providing required KPI data, etc. Supporting / leading projects including working as part of a multidisciplinary team as required. Contributing to the overall improvement of the company from a Quality / GMP / Compliance perspective with an emphasis on continuous improvement of the quality system. Any other duties assigned by Quality Management. MORE INFORMATION ON THIS ROLE AVAILABLE TO VIEW AT WWW.QARESOURCES.COM