Executive - Quality Control

• Ensure effective functioning of Microbiology Laboratory by carrying out analysis
• Ensure the compliance to cGMP regulations, quality guidelines and local SOPs.
• Ensure online documentation.
• Planning and execution of Microbiological activities & online documentation.
• Microbiological testing of finished product, starting material, stability sample & another sample.
• Microbiological media preparation and its GPT.
• Daily monitoring of Area / room & refrigerator/ Incubators temperatures,
• Microbiological monitoring of classified areas.
• Bacterial culture maintenance and keeping records of consumption of ATCC/NCTC cultures.
• Sampling & Analysis of water samples for microbiological parameters.
• Analysis of compressed air and nitrogen gas.
• Report all deviations, which may have impact on safety, identity, strength, purity & quality of drug substance/ product.
• Issuance of QC analytical data sheets
• Trending & review of microbial analytical data for water samples, RM, FG samples.
• Monitoring & perform the calibration / validation for Instruments / Equipment in micro-Lab.
• Preparation and destruction of Media and culture.
• Preparation of Microbial inoculum.
• To perform safe Laboratory operations (as per MSDS) ensuring proper usage of PPEs
• To ensure work permit system during maintenance activities.
• To perform Autoclave validation.
• To carryout in-house Microbial flora isolation process.
• To perform fogging activity as per schedule.
• Daily review & prints out of Incubator when it required.
• To identify & communicate incidents, QEHS nonconformities, investigate and take corrective actions on the same.

To perform Microbial assay.