Yogesh Bhonge

QC/QA Microbiology Deputy Manager with 10+ years of progressive pharmaceutical experience across sterile injectable/parenteral, oral solid dosage (OSD), API, and RIFA manufacturing. Demonstrated expertise in sterility assurance, environmental monitoring (EM), microbiological method validation, contamination control strategy (CCS), and regulatory compliance. Currently leading a greenfield microbiology department in Kinshasa, Africa, setting up laboratory systems from the ground up in alignment with WHO regulatory standards.

Successfully supported 30+ regulatory agency audits including USFDA, MHRA, TGA, ANVISA, WHO, Health Canada, and SAHPRA with zero critical observations in microbiology. Proven leader in team development, aseptic process simulation (media fill), CAPA management, OOS/OOT investigations, and data integrity. Proficient in LIMS, SAP, Trackwise, and ELMS platforms.

Deputy Manager - Quality Control Microbiology / Head of Microbiology Department (Greenfield Project) at Phatkin Laboratory (Dosch Pharmaceutical) (2025-06 – Present)

• Designed and established microbiology laboratory infrastructure for injectable, OSD, and RIFA manufacturing from the ground up, including SOP and specification authoring, equipment qualification, CSV, and LIMS implementation.
• Oversee environmental monitoring programs (viable/non-viable), media fill aseptic process simulation, sterility testing, and contamination control strategy per EU Annex 1, USP, and WHO guidelines.
• Lead, train, and mentor a cross-functional microbiology team on aseptic technique, data integrity (21 CFR Part 11), SOP compliance, and cGMP best practices.
• Drive CAPA development, change control, deviation management, OOS/OOT investigations, and risk assessments (FMEA/FMECA) using ELMS platforms.
• Manage qualification and validation of microbiological instruments and computer systems; maintain audit trail compliance across LIMS and laboratory systems.
• Partner with QA, Production, Engineering, and Regulatory Affairs to align contamination control and sterility assurance strategies with manufacturing goals.

Assistant Manager - Quality Assurance Microbiology Department at Cipla Ltd (Indore SEZ) (2020-09 – 2025-06)

• Reviewed and approved reports for environmental monitoring, MLT, sterility, bioburden analysis, water analysis, growth promotion testing, CCIT, method validation, qualification, media fill, PET, bioassay, and DET autoclave validation.
• Performed QMS activities including Trackwise (as QA Coordinator), LIMS, SAP release, change control/change request, deviation management, SOP implementation, and incident investigations.
• Led OOAL/OOAC/OOS and OOT investigations using cross-functional teams (CFT), root cause analysis (RCA), and FMECA tools.
• Maintained audit trail compliance for laboratory instruments and equipment including ICDAS 2.1, IPV Microbe, THEMA4 Autoclave, Vitek-2, Equisoft, Leucine, Cipdox, and LIMS 6.0.
• Prepared environment and water trend reports, schedules, QMS summaries, and microbiology study protocols; calculated and established alert and action limits.
• Ensured data integrity and audit trail compliance with 21 CFR Part 11 and ALCOA+ principles across LIMS 6.0/7.2, ICDAS 2.1, IPV Microbe, Vitek-2, THEMA4, Equisoft, and CaliberLims.
• Authored and reviewed SOPs, protocols, risk assessments, EM/water trend summaries, and QMS reports; coordinated training and documentation for inspection readiness.
• Collaborated with QA and Production teams to resolve contamination events and supported audit preparation and regulatory inspection readiness.

Senior Officer - QC Microbiology at Intas Pharmaceutical Ltd (2019-07 – 2020-09)

• Executed environmental monitoring, sterility testing, MLT, bioburden analysis, and water system testing for injectable manufacturing in compliance with USP/BP/EP pharmacopeias and cGMP requirements.
• Supported media fill aseptic process simulation activities and area qualification studies; contributed to microbiological trend analysis and alert/action limit reviews.
• Participated in OOS/OOT investigations, CAPA implementation, and deviation management while maintaining data integrity across all laboratory documentation.
• Performed environmental monitoring, microbial limit testing, sterility testing, bioburden, BET/LAL, and growth promotion tests (GPT) for batch release of injectable products.
• Designed and executed microbiological method development and validation studies; led area and equipment qualification activities.
• Performed and reviewed sterility testing, MLT, bioburden/bioload, BET (LAL), CCIT, DET, AET, and growth promotion tests per USP, BP, and EP pharmacopeial standards.
• Participation in CSV activities for QC and EM-related systems including URS, risk assessment, IQ/OQ/PQ, and periodic review.

Officer - QC Microbiology at Emcure Pharmaceutical Ltd (2016-01 – 2019-06)

• Managed and performed environmental monitoring programs across ISO 5-8 cleanrooms including isolator-based, cRABS, oRABS, PFS, and lyophilized suites; established and maintained alert/action limits with trend analysis.
• Led root cause investigations using RCA, FMEA, and cross-functional team (CFT) tools for OOS, OOAL, OOAC, and OOT results; authored CAPA plans and tracked closure within Trackwise.
• Managed WFI and purified water (PW) sampling, testing, and trend reporting, ensuring compliance with pharmacopeial and in-house specifications.
• Supported media fill aseptic process simulation activities and area qualification studies; contributed to microbiological trend analysis and alert/action limit reviews.
• Performed qualification of LIMS 7.2 for QC Microbiology, including IQ/OQ/PQ execution, test script review, and documentation aligned with 21 CFR Part 11 and GAMP 5 expectations.

M.Sc. in Microbiology – North Maharashtra University (2013 – 2015)

B.Sc. in Microbiology – North Maharashtra University (2010 – 2013)