We’re currently recruiting for an exciting opportunity with an award winning Pharmaceutical organization based in Cork. This is an excellent opening for anyone who is looking to join a leading multinational who are one of the best at what they do.
Active engagement with the Technical Operations team, delivering a successful outcome to all Technical Operations activities using Good Manufacturing Practices (GMP). These activities include, but are not limited to, Performance Qualification (e.g. Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies, Media Challenge), Cleaning Validation, Process Validation, Change Control, Exception/Event Investigations/Closure.
• Conduct Technical Operations activities in compliance with US and EU regulations, JSI procedures and EHS&S requirements.
• Develop Technical Operations documentation as required (e.g. strategies, plans, protocols, procedures, reports).
• Review and approve documents prepared by the Technical Operations.
• Execute Technical Operations protocols as 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.
• Prioritize Technical Operations activities in line with the 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.
• Assist in the development of training material for Technical Operations activities.
• Domestic and international travel may be required.
Experience & Qualifications
• Bachelor’s Degree in a scientific/technical discipline required
• Experience in Validation (e.g. Performance Qualification (e.g. Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies, Media Challenge), Cleaning Validation, Process Validation).
• 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 you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480