Assistant Manager Micro

Job Description:

Job Description:

We are seeking a skilled and experienced microbiology professional to lead microbial testing and environmental monitoring activities in an API manufacturing setup. The Assistant Manager will ensure compliance with regulatory standards, supervise microbiological operations, and support quality systems in the microbiology lab.

Key Responsibilities:

• Oversee routine microbiological testing of raw materials, intermediates, water, and environmental samples

• Manage environmental monitoring (EM), compressed air, and personnel monitoring in classified areas

• Supervise microbial limit tests, endotoxin tests, and bio-burden analysis

• Ensure adherence to cGMP, GLP, and regulatory guidelines (ICH, WHO, USFDA)

• Maintain and calibrate laboratory equipment such as autoclaves, incubators, and particle counters

• Investigate microbiological deviations, OOS/OOT, and implement CAPAs

• Prepare and review SOPs, protocols, and reports

• Lead microbial method validation and disinfectant efficacy studies

• Train microbiology analysts and maintain lab hygiene and safety practices

• Support internal and external audits and implement continuous improvements

Key Skills & Competencies:

• Strong knowledge of microbiological testing and aseptic techniques

• Understanding of cleanroom classifications and EM practices

• Experience with API manufacturing processes

• Knowledge of regulatory requirements (USFDA, EU GMP, WHO)

• Proficient in handling investigations and documentation

• Team leadership and training abilities

• Familiarity with data integrity and ALCOA+ principles