Job Description
We’re currently recruiting for an exciting opportunity with an award-winning Biopharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.DutiesDevelop Technical Operations documentation as required (e.g. strategies, plans, protocols, procedures, 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 with routine operations / project based workPrepare 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.Co-ordinate Technical Operations document review and approval.Collate and organize Technical Operations files for turnover to QADC.Attend identified training, required to fulfil the role of a Technical Operations Specialist.Education & ExperienceBachelors Degree in a scientific/technical discipline requiredExperience in Projects, New product introduction (e.g. Supporting: Process Improvement Projects / Process Validation campaigns)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. #J-18808-Ljbffr