ॐ नमः शिवाय शिव

I am a dedicated QA Microbiology Professional with more than 9 years of experience in pharmaceutical quality control and sterile manufacturing environments. I have hands-on expertise in Quality Management Systems (QMS), Sterility Assurance, Environmental Monitoring, Validation, Qualification, Regulatory Compliance, and Audit Readiness. Throughout my career, I have worked with USFDA, MHRA, TGA, EU-GMP, WHO, and PIC/S compliant facilities and have successfully contributed to quality improvement initiatives, microbiological investigations, CAPA implementation, and laboratory compliance.

I am a proactive team player with strong analytical, problem-solving, and leadership skills, committed to maintaining the highest standards of product quality and patient safety.

Senior Executive – Quality Control Microbiology - Ananta Medicare Limited - Sri Ganganagar, Rajasthan

(2024-12)

• Handling QMS activities including Change Controls, Deviations, Incidents, Investigations and CAPA.
• Performing Root Cause Analysis and Risk Assessment for quality events.
• Supporting audit readiness and regulatory compliance activities.
• Reviewing microbiology documents and laboratory records.
• Trending microbiological data and quality metrics.
• Coordinating with QA, Production and Engineering departments.
• Supporting EU-GMP and PIC/S compliance initiatives.

Senior Executive – Microbiology - Sun Pharmaceutical Laboratories Ltd. - Vadodara, Gujarat

(2022-06 - 2024-12)

• Sterility Testing and Sterility Validation.
• BET Analysis and Validation.
• Environmental Monitoring Program Management.
• OOS, OOT, CAPA and Investigation Handling.
• LONZA MODA FDC & EM Software Management.
• Media Preparation and Trend Analysis.
• Audit Trail Review and Regulatory Compliance Activities.
• Participation in HVAC Qualification and Facility Projects.

Officer – Microbiology - IPCA Laboratories Ltd. - Ratlam, Madhya Pradesh

(2020-03 - 2022-05)

• Environmental Monitoring Trend Analysis.
• Microbial Limit Testing and Validation.
• Water Testing and Water System Validation.
• Culture Maintenance and Identification.
• GPT and GIT Execution.
• VITEK 2 Compact Operation.
• Container Closure Integrity Testing.
• Media Preparation and Qualification.
• Environmental Monitoring in Aseptic Areas.
• Media Fill Simulation Activities.

Officer – Microbiology - Mankind Pharma Ltd. - Paonta Sahib, Himachal Pradesh

(2017-01 - 2020-02)

• Environmental Monitoring in Sterile Manufacturing Areas.
• Active Air Sampling and Surface Monitoring.
• Swab and Settle Plate Monitoring.
• Culture Maintenance.
• GPT and GIT.
• Media Preparation.
• Disinfectant Preparation and Qualification.
• Media Fill Activities.

Master of Science - Microbiology - CCS University (2016)

Bachelor of Science - Biotechnology - CCS University (2013)