Experience

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  FDAQRC

  • Texas, United States

  • International Consultant Freelance (GMP Compliance Advisor & Auditor)

    • May 2023 - Present
    • Texas, United States

    Consults with the clients in the pharmaceutical industries to develop quality assurance and regulatory strategies for compliance with applicable regulatory bodies. Assessment of drug substance (active pharmaceutical ingredients) manufacturing sites for regulatory compliance. US Compliance Assessments.

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  venus gmp consultancy

  • Pune, INDIA

  • GMP Compliance Advisor & Auditor

    • Aug 2022 - May 2024
    • Pune, INDIA

    Consults with the clients in the pharmaceutical industries to develop quality assurance and regulatory strategies for compliance with applicable regulatory bodies. Assessment of drug substance / drug product (especially active pharmaceutical ingredients) manufacturing sites for regulatory compliance. EU Compliance Assessment. Compliance project involving QA oversight / assessment of the manufacturing facility for the Russian regulatory authority; Contract Development and Manufacturing Organization (CDMO), India for the European clients.

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  FREELANCE (GMP) CONSULTING

  • India

  • GMP Compliance Advisor & Auditor

    • Jun 2022 - May 2024
    • India

    GMP Audits (Active Pharmaceutical Ingredients, Intermediates, Regulatory Starting Materials and Excipients) and Compliance

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  PQE Group

  • Bengaluru Area, India

  • GMP Compliance Advisor & Auditor

    • Dec 2015 - May 2022
    • Bengaluru Area, India

    GMP AUDITS & ASSESSMENTS: Executed 135 (119 on-the-site and 16 virtually) audits with Corrective Action and Preventive Action (CAPA) follow-up for not less than 70, majorly for the manufacturers of active pharmaceutical ingredients (APIs) and minimally for finished dosage formulations (FDFs) for various Indian, Polish, French, Portugal, Costa Rican, Spanish, German, Greek, Italian, Israeli, Brazilian, Mexican, Japanese and American customers. PROJECTS: (i) Support for Historical Data Review for FDA 483 Form response (Windlas Healthcare, INDIA), (ii) Support for drafting FDA 483 responses (for Chennai, INDIA site of Trifarma, ITALY), (iii) Data Integrity Investigational Support (for Aurangabad, INDIA site of AMRI, USA) and (iv) Data Integrity and Quality Investigational Support (Fresenius Kabi Oncology Limited, Kalyani, INDIA)

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  INDENA INDIA PVT. LTD.

  • Head - Quality Control

    • Nov 2005 - May 2015

    Directed and managed all the activities of Quality Control (Chemical / Physico-chemical and Microbiological) and In-Process Control department. Coordinator from Indena India Pvt. Ltd. (Bangalore), to Indena SpA (Settala and Milan, Italy), Indena SAS (Tours, France), Indena Biotechnology (Shanghai, China), and other Indian as well as overseas customers. Responsible for all the activities of the Quality Control department to ensure compliance with company, compendia, regulatory, and customer requirements managing with a staff of over 16 associates. Study of analytical trends concerned with seasonal variations of chemical constituents in various plant materials of interest growing in the Indian subcontinent and in European landscapes.

  • Analytical Chemist - Quality Control

    • Nov 2002 - Nov 2005

    Performing Quality Control tests for various plant materials, reagents, solvents, products, and packaging materials as per the various pharmacopeias / standard test procedures and specifications and documenting the same with raw data as per the regulatory / company approved methods and policies. Appropriate usage of laboratory instruments and equipment like Analytical Balance, GC, HPLC, UPLC, UV-Vis Spectrophotometer, Polarimeter, Automatic Titrator / Potentiometer and their qualification and routine calibrations.

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  POLLU TECH AIDS

  • Bengaluru Area, India

  • Chemist (In-Process Control)

    • May 2002 - Oct 2002
    • Bengaluru Area, India

    Chemist performing in-process testing of field samples (Raw Water and Waste Water) and registration in the raw data sheets and analytical report.

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  NOVARTIS INDIA LIMITED

  • Bengaluru Area, India

  • Logistics & Inventory Clerk

    • Oct 2001 - Apr 2002
    • Bengaluru Area, India

    Managing (Receipt, Storage, Maintenance, and Issuance) medicines (Finished Dosage Forms, Healthfoods, and babycare products) stocks. More of a clerical nature on a day-to-day basis supporting the supply chain department.

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  CS AEROTHERM PVT. LTD.

  • Bengaluru Area, India

  • Logistics & Inventory Clerk

    • Feb 2001 - Sep 2001
    • Bengaluru Area, India

    Managing (Receipt, Storage, Maintenance, and Issuance) mechanical commodities as stocks. More of a clerical nature on a day-to-day basis supporting supply chain and production departments.