-
Job Description
Technical Operations Specialist role involves developing documentation, reviewing and approving documents, executing protocols, and coordinating document review and approval.
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.
Key Responsibilities:
- Develop 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 work.
- 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.
- 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.
Requirements:
- Bachelors Degree in a scientific/technical discipline required.
- Experience 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 c GMP regulations and guidelines to all aspects of Technical Operations activities.