QC Microbiologist

Job Objective
1.Perform complete Microbiological testing.
2.Lay down systems and practices for ensuring FTR, microbiological quality of products.
In order to ensure production and delivery of microbial compliant capsules.
B.
Primary responsibilities
Strategy & Planning
Functional
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.
•Timely analysis release and COA preparation of finished goods.
•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.
•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

C.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.