Senior Executive - Microbiology compliance

Role & responsibilities

• Ensure compliance with all regulatory requirements and company procedures/policies across microbiology laboratories at all manufacturing facilities sites.
• Act as SME Microbiology for conducting internal audits and reviewing compliance responses across the company .
• Initiate, review, and approve Quality Management System (QMS) elements such as Change Controls, Deviations, Exceptions, and PNCs in respective software platforms.
• Conduct audits for material suppliers, service providers, and contract testing laboratories.
• Prepare, review, and approve Standard Operating Procedures (SOPs) and Policies related to microbiological operations.
• Perform gap assessments of CQA procedures against current regulatory requirements and observations related to microbiology.
• Deliver training sessions on procedures, policies, and regulatory guidance documents.
• Review all microbiological activities including:
• Sterility testing, BET, MLT
• Environmental monitoring
• Culture handling, media preparation
• Water sampling and testing
• Trend analysis, LBPC, bioassay
• AET/PET, bioburden
• Cleaning/sanitization/fogging
• Disinfectant preparation, usage, and efficacy studies
• Gowning qualifications, hold time studies, method validations
• Review Aseptic Processes, including Media Fill simulations and associated documentation.
• Verify Audit Trails related to microbiology software systems.
• Review Microbiologist qualifications and training records.
• Oversee Isolate Identification and Library Maintenance for environmental and water isolates.

Preferred candidate profile

• Experience with isolator/RABS technology.
• Familiarity with rapid microbiological methods (RMM).
• Proficiency in microbiology software systems and audit trail verification.
• In-depth knowledge of GMP, FDA, EU, WHO, and PIC/S guidelines.
• Experience in managing QMS systems and regulatory audits.
• Strong analytical, documentation, and communication skills.