Dhruvaraj K

Responsible for microbiological quality control of raw materials, finished products, water systems, and environmental monitoring.

Perform and review tests such as sterility testing, microbial limit tests, endotoxin (BET), and environmental monitoring as per pharmacopeial standards (IP, BP, USP).

Ensure compliance with GMP, GLP, and regulatory requirements.

Prepare, review, and maintain SOPs, protocols, validation reports, and microbiology-related documentation.

Handle investigations related to OOS, deviations, CAPA, and change controls.

Support internal, customer, and regulatory audits; respond to audit observations.

Manage microbiology lab activities, including media preparation, culture handling, and equipment qualification/calibration.

Train and supervise junior staff and ensure adherence to safety and quality standards.

Assistant Manager – QC Microbiology (Pharmaceuticals)

Pharmaceutical Industry | 6+ Years of Experience

Extensive experience in microbiological quality control of raw materials, finished products, water systems, and environmental monitoring.

Performed and reviewed Sterility Testing, Microbial Limit Tests (MLT), Bacterial Endotoxin Test (BET), and environmental monitoring as per IP, BP, and USP.

Ensured compliance with GMP, GLP, and regulatory guidelines in routine laboratory operations.

Prepared, reviewed, and implemented SOPs, protocols, and microbiology-related documentation.

Investigated OOS, deviations, and incidents; implemented CAPA and change control activities.

Handled internal, external, and regulatory audits; supported responses to audit observations.

Managed microbiology laboratory activities including media preparation, culture handling, and lab hygiene.

Coordinated equipment qualification, calibration, and validation activities related to microbiology.

Trained and supervised junior staff to ensure adherence to quality, safety, and compliance standards.

MSc Microbiology General