Microbiologist

Core

Plan for sampling & testing of raw materials, finished products, in-process samples, swabs, air and water, stability samples as per the given QC plans and customer specifications for microbiological testing and monitoring

Sampling and Environmental monitoring

Analysis and reporting (including SAP entry and COA)

Trending, Investigation and CAPA for microbiological failures

Surveillance for microbiology compliance

Calibration and validation (testing support, laboratory equipment qualification, method validation, disinfectant validation)

GLP and documentation, laboratory facility maintenance

Release of raw material (in absence of QC Head)

Preparation of Microbial SOPs and STPs

Participate in various quality improvement programs and organizational initiatives

Isolation and identification of isolates and maintenance of standard culture

People Development

A. Key Result Areas

• Timely completion and reporting of all Microbiological testing to enhance smooth production activity
• No external failures for microbiology
• No non-compliance in internal and external audits
• Improvement in microbiology trends