Summary

Work experience

• Lead Site Quality

  Biofarma group

  2018.01-Current

  (8 years)

  Spearheaded quality operations for FDA & NSF approved organization with multiple products portfolios of Cosmetics, Nutraceuticals, Specialty products, Amino acids in bulk or intermediate form. Developed and implemented robust CAPA processes, improving compliance and reducing repeat deviations by 50%. Led 20+ successful regulatory audits with zero critical & major observations; reduced audit findings by 50% through proactive gap assessments. Establish and directed supplier qualification program, onboarding 60+ vendors including 40+ for our global manufacturing operations based in Italy, France and USA with robust quality agreements and audits, cutting material rejections. Establish a site-wide Quality Culture/training program, increasing GMP compliance awareness and reducing documentation errors. Oversaw complaint handling system; reduced complaint closure time by 30% through streamlined investigation processes. Played a key role in cross-functional decision-making for product recalls, change controls, and deviation closures. Point of contact for Regulatory affairs.
• Quality Assurance Manager

  Gracure Pharmaceuticals Ltd

  2017.04-2018.05

  (a year)

  Successfully led the site compliance & QC teams for EU GMP audit. Collaborated with R&D team, design and implemented the R&D QA system to upgrade the GMP system in R&D department. Designed a risk-based audit program that improved supplier compliance by 25%. Managed batch record reviews and release processes for 100+ products of different pharmaceuticals dosages, maintaining 99% on-time in full delivery. Developed supplier qualification program, execute the supplier audits and managed corrective actions for critical supplier issues. Equipment commissioning and qualification. Cleaning validation and process validation.
• Assistant Manager (Corporate QA)

  Cipla Ltd

  2015.07-2017.04

  (2 years)

  Customer-Focused Compliance: Directed QC operations for 15+ pharmaceutical and biotech CMO, ensuring alignment with diverse regulatory requirements (FDA, EMA, Health Canada,ANVISA). Maintained 100% on-time batch releases and zero product recalls over 2 years. Data Integrity and electronic control: Implemented electronic Quality Management Systems (eQMS), leading to a 25% increase in operational efficiency. Tech Transfer Success: Led QA oversight for 12+ tech transfers (oral solid dose, sterile injectables),achieving 20% faster validation timelines through proactive gap analysis and client-collaborative protocol design.
• MHRA approved, manufacturer of antibiotics

  Indoco Remedies Ltd.

  2010.11-2015.07

  (5 years)

  Oral liquid and export drugs to UK and European Union.
• A MNC Pharma manufacturing OSD, liquid

  Glenmark Pharmaceutical Ltd..

  2010.05-2010.11

  (7 months)

  tablets, capsules and topical supplying to US, UK and European Union.
• Manufacturer of OSD, liquid and oral solutions

  Indoco Remedies Ltd.

  2008.05-2010.05

  (2 years)
• An Indian Pharma company specialized in antibiotics etc.

  FDC Ltd.

  2006.04-2008.05

  (2 years)

  The major responsibilities and work performed during above tenure is QC laboratory, analytical testing and GLP. The major areas of expertise are: Sampling and testing of raw materials, finish products and packaging material samples. Recording and release of material in ERP software. Calibration of QC instruments. Preparation and reviewing of Standard Operating Procedures, testing methods and report sheets. QC non conformances (OOS/OOT, deviation etc.) investigation and root cause analysis (RCA). Analytical method validation and technology transfer.

Educational experience

• Vinayaka Mission University, Salem, India

  Chemistry

  2004.09-2006.04

  (2 years)
• Himachal Pradesh University, [Shimla]

  Biology (Chemistry, Zoology & Botany)

  2000.09-2004.07

  (4 years)

Certificates