Job Description
We're seeking a Technical Operations Specialist to join an award-winning Biopharmaceutical organization in Cork. Key responsibilities include developing documentation, reviewing and approving reports, executing protocols, and coordinating document review. A Bachelor's degree in a scientific or technical discipline is required, as well as experience in projects, new product introduction, and knowledge of FDA/EMEA regulatory requirements. The ideal candidate will have strong analytical and problem-solving skills, with the ability to apply cGMP regulations and guidelines to all aspects of Technical Operations activities. Key Responsibilities: • Develop Technical Operations documentation, including strategies, plans, protocols, procedures, and reports • Review and approve documents prepared by other Technical Operations colleagues • Execute Technical Operations protocols as required • Liaise with Manufacturing to provide support where required • Prepare reports for executed protocols for review and approval • Initiate and implement change control activities in accordance with site procedures • Track and resolve exceptions/events/deviations during Technical Operations activities • Coordinate Technical Operations document review and approval • Collate and organize Technical Operations files for turnover to QADC • Attend identified training, required to fulfill the role of a Technical Operations Specialist Requirements: • Bachelor's degree in a scientific or technical discipline • Experience in projects, new product introduction • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals • Ability to apply cGMP regulations and guidelines to all aspects of Technical Operations activities