Dipti Kelkar

A versatile and result-oriented professional with over 10 years of extensive experience as a Microbiologist in In-Process Quality Control (IPQC) and In-Process Quality Assurance (IPQA) within the pharmaceutical and healthcare industries. Proven expertise in handling diagnostic and industrial microbiology operations, environmental monitoring, water analysis, and regulatory compliance documentation. Adept at managing internal and external audits, including WHO and FDA inspections, drafting standard operating procedures (SOPs), and validating laboratory instruments and manufacturing processes.

Senior Microbiologist - Shreechem Pharmaceutical Pvt. Ltd.

(2026-06)

• Perform daily Microbial Limit Testing (MLT) of process water, finished pharmaceutical products, and raw packing materials.
• Conduct advanced sterility testing, encompassing comprehensive packing material and finished product sterility evaluations.
• Execute Bacterial Endotoxin Testing (BET) and precise antibiotic assays to meet stringent quality matrices.
• Possess and apply deep technical knowledge in sterility guidelines, assay verification, and real-time laboratory reporting.

Consultant Microbiologist - VVF India Limited

(2025-05 - 2026-06)

• Conducted specialized testing of Pharma grade glycerine alongside standard microbiological analysis of DM water, finished products, packing materials, and environmental monitoring.
• Utilized SAP systems efficiently for marketing samples, generating sales orders, and verification of real-time material status.
• Successfully faced and addressed queries during rigorous internal and external compliance audits.

Senior Executive Microbiologist - Danashmand Organics Pvt. Ltd.

(2022-12 - 2024-08)

• Acquired hands-on experience in complex water analysis, environmental monitoring, swab analysis, final product clearance, and packing materials micro-analysis.
• Faced WHO, FDA, and multiple third-party audits with immediate preparation of audit compliance answers.
• Leveraged personal FDA approval to formally authorize and manage final compliance documentation for the organization.
• Drafted, reviewed, and updated standard operating procedures (SOPs) and corresponding validation workflows.

Senior Executive (QC & Microbiology) - Abhinav Health Care Products Pvt. Ltd.

(2020-06 - 2022-12)

• Played a pivotal role in handling In-Process Quality Control (IPQC) and In-Process Quality Assurance (IPQA) checkpoints.
• Conducted exhaustive microbial analysis of diverse finished products including tablets, syrups, granules, and capsules.
• Drafted comprehensive SOPs for packing materials, the microbiology lab, and FMB sections while closely monitoring technical execution.
• Monitored environmental microorganism development, grew pure microbe cultures, and tracked water purity (DM water, raw water).
• Utilized specialized laboratory equipment (including electron microscopes) and software for tracking drug attributes and clinical trials.

Lab Technician - Keskar Diagnostics Services

(2018-04 - 2020-02)

• Delivered diagnostics microbiology testing services for regional health departments, community health programs, and consulting physicians.
• Maintained high accuracy in sample management, laboratory documentation, and initial clinical processing.

Microbiology Officer - Benzo Chem. Industries Pvt. Ltd.

(2014-12 - 2016-12)

• Performed detailed in-house microbiological assays, steam attribute validations, water analysis, and raw material sampling.
• Maintained precision across routine culture maintenance and equipment sterilization procedures.

Deputy Technical Officer - Ajay Shah Pathological Lab & Reference Center

(2011-08 - 2013-11)

• Managed daily lab operations, extensive media preparations, bioburden testing, and microbial identification matrices.

B.Sc. - Microbiology - Vidya Pratishthan's Art, Science, Commerce College, Baramati (2007)

Post Graduate DMLT - C.K.T. College, Panvel