Officer/ Jr. Officer

Role & responsibilities

• Perform Microbial Limit Testing (MLT) and Microbial Enumeration Testing.
• Conduct Sterility Testing for raw materials, in-process samples, and finished products.
• Perform Bacterial Endotoxin Testing (BET).
• Carry out microbiological testing of Purified Water (PW) and Water for Injection (WFI).
• Perform microbiological testing and monitoring of utilities, including Nitrogen, Pure Steam, and Compressed Air.
• Conduct Environmental Monitoring, including Air Monitoring and Surface Monitoring, in cleanroom and controlled areas.
• Prepare, sterilize, and manage culture media as per approved procedures.
• Perform Microbial Identification and maintain related documentation.
• Conduct Disinfectant Efficacy Studies / Disinfectant Qualification Studies.
• Support microbiological monitoring activities in aseptic and injectable manufacturing areas.
• Ensure compliance with GMP, GLP, SOPs, and applicable regulatory guidelines.
• Maintain accurate records, logbooks, test reports, and laboratory documentation.
• Support investigations related to deviations, OOS/OOT results, contamination incidents, and environmental monitoring excursions.
• Ensure proper cleaning, maintenance, calibration, and operation of microbiology laboratory equipment.
• Follow data integrity, laboratory safety, and good documentation practices.

Preferred candidate profile

• Experience in Pharmaceutical Injectable and Biosimilar Manufacturing.
• Hands-on knowledge of Sterility Testing, BET, MLT, Environmental Monitoring, and Microbial Identification.
• Understanding of aseptic practices and cleanroom monitoring.
• Good knowledge of GMP, GLP, GDP, and microbiological laboratory practices.
• Good documentation, analytical, and communication skills.