Microbiologist Executive

Exemed; Padra; On-site; INR 550,000 - 900,000; Full time

Job summary

Exemed is seeking a microbiology analyst to perform microbiological analyses of water, raw materials, and APIs within a GMP environment. You will conduct environmental monitoring in classified manufacturing areas, perform GPT and culture maintenance, and ensure data integrity in all records.

Responsibilities include trend analysis, CAPA support, instrument calibration, and collaboration with QA, Production, and Validation teams.

Responsibilities

• Perform microbiological analysis of purified water, potable water, compressed air, nitrogen, and other utility samples as per approved procedures.
• Conduct Environmental Monitoring (EM) of classified manufacturing areas, microbiology laboratories, warehouses, and utility areas using active air sampling, settle plates, contact plates, and surface swabs.
• Perform microbial limit testing and bioburden analysis of raw materials, intermediates, and APIs, wherever applicable.
• Prepare, sterilize, qualify, and maintain microbiological media, reagents, and laboratory solutions.
• Perform Growth Promotion Test (GPT), media qualification, and culture maintenance activities.
• Carry out microbial identification using approved microbiological techniques and maintain reference cultures.
• Perform trend analysis of environmental monitoring and utility monitoring data and report any adverse trends.
• Ensure routine calibration, qualification, verification, and preventive maintenance of microbiology laboratory instruments and equipment.
• Maintain laboratory notebooks, worksheets, logbooks, analytical records, and electronic data in compliance with ALCOA+ and data integrity principles.
• Investigate Out-of-Specification (OOS), Out-of-Trend (OOT), environmental monitoring excursions, laboratory deviations, and support implementation of Corrective and Preventive Actions (CAPA).
• Ensure compliance with cGMP, GLP, SOPs, EHS policies, and applicable pharmacopeial requirements (USP, EP, IP).
• Coordinate with QA, Production, Engineering, Validation, and Maintenance departments for microbiological investigations and contamination control activities.
• Participate in qualification and validation activities related to cleanrooms, utilities, equipment, and microbiological methods.
• Support internal audits, customer audits, and regulatory inspections by providing microbiology-related documentation and technical information.
• Maintain laboratory housekeeping, biosafety standards, and inventory of microbiological media, reagents, cultures, and consumables.
• Contribute to continuous improvement initiatives to strengthen microbiological controls and laboratory efficiency.

Job description

Role & responsibilities

• Perform microbiological analysis of purified water, potable water, compressed air, nitrogen, and other utility samples as per approved procedures.
• Conduct Environmental Monitoring (EM) of classified manufacturing areas, microbiology laboratories, warehouses, and utility areas using active air sampling, settle plates, contact plates, and surface swabs.
• Perform microbial limit testing and bioburden analysis of raw materials, intermediates, and APIs, wherever applicable.
• Prepare, sterilize, qualify, and maintain microbiological media, reagents, and laboratory solutions.
• Perform Growth Promotion Test (GPT), media qualification, and culture maintenance activities.
• Carry out microbial identification using approved microbiological techniques and maintain reference cultures.
• Perform trend analysis of environmental monitoring and utility monitoring data and report any adverse trends.
• Ensure routine calibration, qualification, verification, and preventive maintenance of microbiology laboratory instruments and equipment.
• Maintain laboratory notebooks, worksheets, logbooks, analytical records, and electronic data in compliance with ALCOA+ and data integrity principles.
• Investigate Out-of-Specification (OOS), Out-of-Trend (OOT), environmental monitoring excursions, laboratory deviations, and support implementation of Corrective and Preventive Actions (CAPA).
• Ensure compliance with cGMP, GLP, SOPs, EHS policies, and applicable pharmacopeial requirements (USP, EP, IP).
• Coordinate with QA, Production, Engineering, Validation, and Maintenance departments for microbiological investigations and contamination control activities.
• Participate in qualification and validation activities related to cleanrooms, utilities, equipment, and microbiological methods.
• Support internal audits, customer audits, and regulatory inspections by providing microbiology-related documentation and technical information.
• Maintain laboratory housekeeping, biosafety standards, and inventory of microbiological media, reagents, cultures, and consumables.
• Contribute to continuous improvement initiatives to strengthen microbiological controls and laboratory efficiency.