GMP Production Scientist MedPharm Ltd
Expires: 01/01/1970
MedPharm is recruiting for a GMP Production Scientist to assist in the running of the GMP clean rooms, storage areas and GMP campaigns to ensure manufacture and packaging of clinical trial material is in line with agreed schedules, customer requests and is compliant with GMP regulations.
Essential Functions:
- To lead manufacture, packaging and labelling campaigns for investigational medicinal products for use in clinical trials.
- Working knowledge of the training requirements set out in Eudralex 2003/94/EC and the application of these regulations to MedPharm’s training policies and procedures.
- To provide technical input for manufacturing projects and clinical trial supplies. Support the Head of Production in performing root cause analysis and OOS investigations.
- Prepare GMP documentation. E.g., batch manufacturing records, quality documents and validation protocols.
- To assist in the running of clean rooms and Production storage areas to ensure compliance with all GxP regulations.
- To assist with the maintenance, calibration, verification and validation of laboratory equipment in line with GxP regulations.
- To assist in the maintenance and cleaning of equipment and utensils in line with MedPharm procedures.
Education and Experience:
- Bachelor’s degree
- Experience within a GMP role
- Experience with EudraLex volume 4, and Annex 13
- Experience in completion of quality records such as change controls and deviations