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Contact Info
Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Technical Operations Specialist - CPV & Lifetime Program


Reference:SMC1668 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Process Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical 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.

Duties

• Conduct Technical Operations activities in compliance with US and EU regulations, and EHS&S requirements.
• Develop Technical Operations documentation as required (e.g. strategies, plans, protocols, procedures, manual and automated reports).
• Statistically analyze data and troubleshoot problems with other departments.
• 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.
• Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
• 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.
• Prioritize Technical Operations activities in line with Manufacturing / the particular project schedule.
• Co-ordinate Technical Operations activities with contractors and vendors as required.
• Co-ordinate 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.
• Participate in cross-functional teams as required.

Education & Experience

• Bachelors Degree in a scientific/technical discipline required
• Experience in Manufacturing (e.g. Supporting: Process Improvement Projects / Process Validation campaigns/Root Cause Problem solving/ Statistical data analysis)
• 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.
• Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.



If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.