Executive - QC Micro

• Role & responsibilities :

• To prepare the disinfectant solutions as per defined procedures.
• To maintain the microbiology laboratory in clean and sanitized state as per standard operating procedure.
• To receive, prepare, standardize and usage of standard microbial cultures as per standard operating procedure.
• Responsible to perform/Report the analysis of Water and pure steam (Condensate) samples.
• Responsible to ensure the good documentation practices/Good laboratory practices.
• Responsible to perform Growth Promotion Test, Indicative Properties & Inhibitory Properties test of microbiological Media.
• To perform Enumeration & testing of Biological Indicator (BI)
• To maintain the equipments in clean and sanitized state as per standard operating procedure.
• Environmental monitoring of microbiology laboratory and production area as per schedule.
• Monitoring of temperature, humidity and differential pressure of microbiology laboratory.
• Discard of used media as per standard operating procedure.
• To perform the Microbial Limit Test, Sterility Test of raw materials and finished products as per standard operating procedure.
• To check and Verify Microbiological Activity.
• To perform the sampling and analysis of compressed air, N2 gas and drain as per schedule.
• To prepare the Environment monitoring Trends as per requirement.
• To prepare the Water analysis Trends as per requirement.
• To maintain the analytical records, log books in online state.
• To perform the swab sampling.
• To maintain the archived documents as per requirements.
• To perform the calibration of balance and pH meter.
• To responsible for release the finish product, Raw material, stability, primary pkg. material and all testing test regarding media.
• To responsible for QMS Activity (change control, deviation, notification).
• To responsible for microbial method validation and data Compilation.
• To responsible for validation and calibration of Equipment/Instrument as per validation and calibration schedule.
• To responsible for performance of Isolation/Identification of Isolates on Vitek-2/Previcolor.
• To responsible for perform the BET analysis of Finish, RM and water.
• To perform any type of activity which is allocated by Department Head/Designee.
• Responsible for Assigned activities as and when required for which required training imparted.

Preferred candidate profile : The candidate must have exposure of minimum 4-5 years in BET & Sterility testing in Injectable plant.