Deputy General Manager - Microbiology (Injectables)

Job Description

Role & responsibilities Key Responsibilities: Lead the Microbiology Laboratory operations for injectable manufacturing in accordance with cGMP and global regulatory guidelines. Oversee and ensure compliance in microbiological testing such as: Sterility Testing Bacterial Endotoxin Testing (LAL) Environmental and Personnel Monitoring Bioburden and Microbial Limit Tests (MLT) Water and utility microbiological assessments (WFI, purified water, compressed air) Design, execute, and review microbiological method validation protocols including: Validation of Sterility Test methods BET (LAL) method suitability and validation Disinfectant efficacy studies Antimicrobial effectiveness testing Microbial recovery studies from various matrices and surfaces Lead cleanroom validations, aseptic process simulations (Media Fills), and HVAC system qualification from microbiological perspective. Serve as subject matter expert (SME) during inspections (EU, PICS, COFEPRIS, WHO-GMP, etc.) and customer audits. Drive root cause analysis (RCA), CAPA implementation, and continual improvement related to microbial excursions or contamination events. Maintain and periodically update SOPs, microbiological risk assessments, and QMS documents. Develop and mentor a team of qualified microbiologists. Coordinate with QA, Production, and Validation teams for cross-functional initiatives and technology transfers. Preferred candidate profile M.Sc. in Microbiology or related field. 1215 years of relevant experience in a sterile pharmaceutical environment with a strong background in injectables . Hands-on expertise in microbiological method validations and regulatory-compliant documentation practices. Proven track record of successful regulatory audits and inspections. Strong grasp of current regulatory guidelines: USP, EP, JP, ICH, WHO TRS , etc. Familiarity with laboratory instrumentation like isolators, automated endotoxin readers, particle counters, and bio-safety cabinets. Desired Competencies: Strong leadership and decision-making skills. Meticulous attention to detail and scientific integrity. Effective communication and team-building abilities. High level of regulatory awareness and industry best practices.