LSC have a great contract opportunity for a Engineering GMP Co-Ordinator to join 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.
If you have 5+ years’ experience working in a Bio-Pharmaceutical or equivalent type industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
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
ABOUT YOU – ARE YOUR SKILLS A MATCH?
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
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
To apply submit your CV via this advert or contact Conor Dolan at LSC on 021-4777329 if you have more questions about this Engineering GMP Co-Ordinator opportunity!