Bhuvaneshwar Yadav

• Senior Quality Control Microbiologist with over 15.5 years of experience in the pharmaceutical industry, specializing in microbiological testing, team leadership, and regulatory compliance. Proven expertise in handling audits (USFDA, ANVISA, MHRA) and managing risk assessment, deviation control, and software validation. Strong background in sterility testing, Bacterial Endotoxin testing, environmental monitoring, and method validation
• Current Affiliation: Company Profile: M/s Zydus Animal healthcare & investment Pvt. Ltd. Pharmez SEZ Ahmedabad Gujarat
• Current Job Profile:
• Leading the Microbiology team.
• Coordinate to cross functional team for timely release of product, validation activities.
• Review of Raw Materials, Finished Product and Stability Product.
• Microbiological investigation through track wise software.
• Handling of deviation, Incident and Out of Specification.
• Handling of Global CAPA and compliance of other locations.
• Responsible for risk analysis with risk assessment of cited discrepancy
• Audit trial review of Vitek 2 compact system, Tiamo software for pH meter and conductivity meter, SCADA system HPHV autoclave, Elite 3.1 stability chamber and Enviro stability chamber
• Review of Environmental & Water Quality Trends.
• Preparation of SOPs, STPs and Validation Protocols related to microbiology department through DMS software, EDMS.
• Responsible for maintaining the JD (Job description) of analyst and also responsible for Timely execution of Training for Analyst
• Work Allocation and Planning in Microbiology Lab
• Timely Calibration and validation of equipment/instrument.
• Water schedule and equipment/instrument calibration schedule through SAP software.
• Microbiological Data review through LIMS software.
• Member of Core team for SOP simplification project at site.
• Coordinate with Vendor for calibration and validation activities.
• Software validation related to microbiology department.
• Responsible for all Internal as well as External Audits
• Indenting of Material through SAP Management System.

Lead the Microbiology team

Coordinate to cross functional team for timely release of product, validation activities.

Review of Raw Materials, Finished Product and Stability Product.

Microbiological investigation through QAMS software

Responsible for risk analysis with risk assessment of cited discrepancy

Preparation of SOPs, STPs and Validation Protocols related to microbiology department through DMS software, EDMS

Performed Sterility Testing, Bacterial Endotoxin Test (BET), and Preservative Monitoring Test (PMT) as per USP/EP/IP.

Followed cGMP, GLP, and aseptic practices during routine microbiological analysis.

Documented, reviewed, and maintained microbiological data and reports.

Investigated OOS/OOT results and supported CAPA activities.

Functioned as Microbiology Reviewer, reviewing sterility, BET, and PMT data for accuracy, compliance, and data integrity.

Performed pharmaceutical water analysis (Purified Water /Raw water) for microbial quality as per USP/EP/IP.

Conducted Microbial Limit Tests (MLT) for raw materials, in-process samples, and finished products.

Performed IQ, OQ, and PQ of microbiological instruments and equipment including autoclaves, incubators, LAF, biosafety cabinets, and colony counters.

Maintained compliance with cGMP, GLP, GDP, and data integrity (ALCOA+) principles.

Prepared and maintained SOPs, validation protocols, reports, and logbooks.

Supported OOS/OOT investigations, deviations, CAPA, and audit activities.

• Water analysis (PW/WFI)
• Sterility testing
• BET analysis
• Bioburden analysis
• GMP documentation & compliance

• Environmental Monitoring (EM) of classified areas including viable and non-viable monitoring in cleanrooms as per regulatory guidelines.
• Conducted Aseptic Process Simulation (Media Fill) activities for sterile manufacturing operations.
• Involved in media fill planning, execution, monitoring, incubation, result evaluation, and report preparation.
• Ensured compliance with aseptic practices, cGMP, and contamination control requirements.
• Documented EM and media fill data accurately and supported deviation investigation and CAPA when required.

• Environmental Monitoring (EM) of classified areas including viable and non-viable monitoring in cleanrooms as per regulatory guidelines.
• Conducted Aseptic Process Simulation (Media Fill) activities for sterile manufacturing operations.
• Involved in media fill planning, execution, monitoring, incubation, result evaluation, and report preparation.
• Ensured compliance with aseptic practices, cGMP, and contamination control requirements.

• Environmental Monitoring (EM) of classified areas including viable and non-viable monitoring in cleanrooms as per regulatory guidelines.
• Conducted Aseptic Process Simulation (Media Fill) activities for sterile manufacturing operations.
• Involved in media fill execution, monitoring, incubation, result evaluation, and report preparation.
• Ensured compliance with aseptic practices, cGMP, and contamination control requirements.
• Documented EM and media fill data accurately and supported deviation investigation and CAPA when required.
• Water analysis Purified water,Water for Injection and Pure steam monitoring.
• BET analysis.
• Media prearation.

• Water analysis
• Sterile API sampling
• Double door autoclave operation.
• Media Preparation.
• Environmental Monitoring (EM) of classified areas including viable and non-viable monitoring in cleanrooms as per regulatory guidelines.
• Conducted Aseptic Process Simulation (Media Fill) activities for sterile manufacturing operations.
• Involved in media fill planning, execution, monitoring, incubation, result evaluation, and report preparation.
• Ensured compliance with aseptic practices, cGMP, and contamination control requirements.
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