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About the job

Pharmaceutical Compliance Officer – Competitive – Athlone/Dublin The Role Kent-Athlone Pharma Group, one of the leading suppliers of medicines and penicillin products across international markets, are seeking a Pharmaceutical Compliance Officer in a QA (quality assurance) capacity. The successful candidate will be responsible for the completion of product quality review, data tracking and trending, and reviewing third party manufacturing activities for compliance to the MA. The key responsibilities of a Pharmaceutical Compliance Officer include, but are not limited to: Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives for assigned products. Review of internal documentation to ensure compliance with license details and relevant guidelines and directives. Develop work processes in conjunction with Compliance Manager and Release QPs, to aid the release of medicinal product batches. Initiate and investigate non-conformances/Process investigations as required where issues detected. Track and investigate any assigned investigations and complete CAPA actions to agreed timeframes. Review and approval of Third Party CMO Master Batch Records (Batch Manufacturing & Packing records, Validation/Stability Protocols and Report, Finished Product Specifications and End of Shelf Life specifications) for assigned products. The Company The Kent-Athlone Pharma Group specialises in the reliable and consistent supply of a wide range of generic and specialty pharmaceuticals and is a leader in anti-infective products manufactured in its modern facility in Athlone, Ireland. The Kent-Athlone Pharma Group was created in September 2019 following Duke Street Capital’s acquisition of Kent Pharmaceuticals, a leading international supplier of medicines, and Athlone Laboratories, a key supplier of penicillin products to global markets. The Person The key skills and qualities of a Pharmaceutical Compliance Officer at Kent-Athlone Pharma Group are: Third Level qualification preferably in a scientific discipline A Working knowledge of quality systems requirements, HPRA, MHRA, EU regulations and ICH guidelines as they relate to Quality Assurance. Experience and knowledge of Good manufacturing practises and associated regulations. A well-organized approach, underpinned by the ability to communicate effectively with people at all levels, both verbally and in writing. Reliability, IT literacy and the ability to plan and complete projects to set timelines is essential. If you are keen on joining this exciting, forward thinking company and taking the next step in your career, then please click the apply now button to find out more

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Dublin,Republic of Ireland