Executive/Sr. Executive, Microbiology

At least 2 years of relevant professional experience in the respective department.

Strong interpersonal and communication skills, with the ability to perform effectively under pressure.

Conduct microbiological testing, including microbial enumeration, specified microorganism identification, sterility testing, endotoxin testing, and bioassay of raw materials, excipients, and finished products.

Perform microbiological analysis of purified water, potable water, water for injection (WFI), source water, and drinking water.

Carry out environmental monitoring activities across designated cleanroom areas.

Prepare microbiological media for routine testing and conduct growth promotion testing to ensure media performance.

Monitor and manage the inventory of culture media, reagents, reference microorganism cultures (ATCC), and related indicators.

Conduct Antimicrobial Effectiveness Testing (AET) as per established procedures.

Execute validation of microbiological test methods, moist heat sterilization processes, and dry heat sterilization processes.

Analyze and prepare trends based on water testing results and environmental monitoring data.

Conduct aseptic process simulations in collaboration with the Production Department and prepare comprehensive final reports, including proper documentation and justification of interventions.

Monitor and coordinate the calibration of microbiology laboratory equipment to ensure accuracy and reliability.

Prepare laboratory reports and review, revise, and maintain SOPs and other relevant documents in compliance with WHO cGMP, BP, and USP standards.