Led a team of microbiologists in ensuring the sterility assurance of pharmaceutical products, strictly adhering to cGMP and GDP regulations.Oversaw the Microbiology Sample Review and Release process, guaranteeing adherence to established standards and procedures.Played a critical role as a core member of the Cross-Functional Team (CFT)for Deviation Investigations, conducting root cause analysis, and successfully implementing corrective and preventive actions (CAPA).Initiated and reviewed essential documentation for Change Control, CAPA, and Deviation Investigations, ensuring meticulous compliance and adherence to regulatory requirements.Effectively managed the Cleaning and Process Validation Document Review processes,fostering seamless collaboration among team members and ensuring comprehensive execution of activities

Managed all aspects of Manufacturing Assurance and Sterility Assurance for all manufacturing Lines, leading and mentoring a team of 8 direct reports.Served as a key member of the Manufacturing Assurance and Sterility Assurance team for FormulationIII, ensuring strict adherence to allapplicable regulations and guidelines.Maintained rigorous adherence to cGMP and GDP principles, guaranteeingthehighest standards of product quality and safety through out the manufacturing process.Oversaw Batch Review and Release activities, meticulously verifying that all products exceeded stringent quality specifications.Reviewed and approved validation-related activities, including Aseptic Process Simulation (Media Fill) and Process Validation, ensuring adherence to established protocols and regulatory requirements.Collaborated effectively within cross-functional teams to thoroughly investigate observations from internal and external audits, proactively implementing corrective actions to address identified areas of improvement.

Manufacturing Assurance

Led a team of microbiologists in ensuring the sterility assuranceof pharmaceutical products, strictly adhering to cGMP and GDP regulations.Oversaw the Microbiology Sample Review and Release process, guaranteeing adherence to established standards and procedures.Played a critical role as a core member of the Cross-Functional Team (CFT)for Deviation Investigations, conducting root cause analysis, and successfully implementingcorrective and preventive actions (CAPA).Initiated and reviewed essential documentation for Change Control, CAPA, and Deviation Investigations, ensuring meticulous compliance and adherence to regulatory requirements.Effectively managed the Cleaning and Process Validation Document Review processes,fostering seamless collaboration among team members and ensuring comprehensive execution of activities

 Analysis of raw material, in-process and finished products & stability samples for variety of Microbiological Limit Tests, PET. Temperature mapping of Refrigerator, incubators. DHS Validation. Review of microbiological testing documents. Team leader handling the testing group including MLT, BET and sterility, Validation activity and QMS related activity. QMS activity: Change control, CAPA, PNC etc.

 Analysis of raw material, in-process and finished products & stability samples for variety of Microbiological Limit Tests. Executing & performing Water Analysis, BET, Culture Dilution, PET, DET Environment Monitoring, GPT, Culture Enrichment and Media Preparation, Ampoule spore count of Geobacillius sterothermophillius. BIs testing, Surface challenge test with disinfectants. Maintaining & validating microbial cultures and conducting validation of media & newly introduced methods

 Involved in conducting chemical Analysis Syrups, water and raw materials such as flavours. Responsible for sampling and analysis of raw material, in-process and finished products & stability samples for variety of Microbiological Limit Tests.Notable Highlights: Successfully prepared MLT Methods for raw materials and finished products. Efficiently handled instruments & lab accessories like: - U.V. Spectrophotometer (Shimadzu- UV 1700)- Refracterometer (Sharthak)- Polarimeter (Sharthak)- pH Meter (Lab India – Phan) - pH & Conductivity Meter (Lab India- Phan)- Analytical Weighing Balance- Vacuum Oven- Hot Air Oven, etc.

 Involved in conducting chemical Analysis Syrups, water and raw materials such as flavours. Responsible for sampling and analysis of raw material, in-process and finished products for variety of Microbiological Limit Tests according to Homeo pharmacopeia of India.