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 valuable 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.
Positive knowledge of GMP, GLP, GDP, and microbiological laboratory practices.
Valuable documentation, analytical, and communication skills.

📌 Officer/ Jr Officer Bhopal
🏢 Eris
📍 Bhopal