QC Analyst (Microbiologist) At Novartis

Job Description

-Conducting different microbiological tests such as non-sterile testing for raw materials and finished goods, sterility testing and bacterial endotoxins testing.
– Execute and review QC testing for in-house prepared nutrient media.
– Execute and review results for different tests including environmental monitoring, sterile & non-sterile testing.
– Execute gram staining and identification for recovered isolates.
– Execute and review environmental monitoring trend results based on required frequency.
– Participate in establishment of microbiological environmental monitoring sampling program for different manufacturing areas.
– Participate in cleaning validation program in different manufacturing areas.
– Participate in qualification activities for utilities and water systems.
– Participate in clean room qualification activities in different manufacturing areas.
– Participate in requalification activities for incubators, autoclaves & depyrogenation equipment.
– Participate in qualification activities for personnel such as gowning qualification for filling personnel in sterile manufacturing area.
– Participate in qualification activities for microbiology personnel.
– Participate in process simulation activities in aseptic manufacturing area.
– Participate in investigations in environmental monitoring deviations, non-complying results for finished products or starting materials.
– Participate in microbiological validation activities such as method suitability for MET and disinfectant efficacy studies.
– Ensure sustainability of lean lab principles, DI & HSE requisites.

Minimum requirements

– Pharmacy background.
– 3-4 years of experience in similar microbiology labs supporting sterile manufacturing.
– TQM or basic six sigma is preferred