Officer / Senior Officer - Microbiologist

Test to a high, and continuously improving, level of GMP/GLP compliance to ensure patient safety and to minimize risk to the company business

 

Perform routine testing and basic GMP paperwork review with supervisor direction

 

Oversee the development and tracking to a plan for day-to-day testing activities to meet the daily manufacturing and batch disposition schedule while maintaining the highest levels of GMP compliance

 

Full responsibility for the operation of the laboratory

 

Frequently review staff training to ensure that that it meets the requirements of the laboratory and fulfil the needs and aspirations of the individual

 

Enhancements and improvements to current commercial processes

 

DCMC Team participation for establishment of sample points and limits/specifications for new products/interfacing with various R&D groups

 

Periodic review of microbial limits

 

Excursion and contamination response harmonization

 

Analyzes data and results and provides conclusions and proposals for future directions