Engineering GMP Coordinator is required for a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long term market support. The team on site grow, purify, formulate and bulk fill mammalian cell culture derived APIs for medicines intended for human use. The site is currently moving from commissioning into full scale commercial operations. This is an opportunity to work in a company that is innovative (ranked 10th most innovative by Forbes) and recognized globally as one of the fastest companies to get medicines to market.
The Engineering Coordinator will:
o Co-ordinate the Project and Facilities Contract personnel GMP compliance programme.
o Support the internal compliance programme within Manufacturing, Warehouse and P&L environments
– Manage the Self Inspection programme
– Management of Contractor GMP Records including the training of contractors on all relevant SOP’s including gowning, material flow etc.
– Develop and Maintain Tracking and Reporting Systems
– Manage the Escalation Process
o Establishment and Management of a GMP Induction programme including training materials for Contract resources
o Lead and Participate in self inspection audits of contract personnel, including regular compliance walk-downs.
The Engineering Coordinator will require:
o Minimum of a Science / Engineering Technical Qualification with 5+ years’ experience working in a Bio-Pharmaceutical or equivalent type industry
o Demonstrated experience in similar role is essential.
o Technical knowledge of FDA and EU regulations is preferred
Call Mairead in LSC on 0214777 329 to discuss this Engineering Coordinator role in more detail or apply directly via this advert.