3 months ago
You will make sure QC activities follow with the requirements of both Pharmaceutical Quality Systems.
You will need experience in clean room tasks as assistance is required
Must be able to create a QC method for GMP testing on products in relation with Process Development teams and Research & Development, to ensure required methods are effective
Perform analysis on batch testing records
Ensure laboratory management including maintenance/calibration of materials/equipment and budget control are sufficient.
Support the Manufacturing facility and licensing including; validation documentation and writing/reviewing SOP's.
You will need the following expertise:
Experience in the gene/cell therapy space
Have great experience and Good knowledge of GMP regulations in US including those that specifically apply for the testing of cell therapy products and/or ATMP's.
IN depth knowledge of writing or reviewing of GMP documents to guarantee regulatory requirements are met within time frames
Strong leaderships and managerial skills in a team environment
B's in Cell/molecular Biology/immunology or Associated sciences.
If this opportunity is of interest to you then please get in touch!
connor.harknett.EU.com or 01737761697