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Kusum Bhanot Arali profile image

Kusum Bhanot Arali

Independent Consultant at FDAQRC
Intro Book
Kusum Bhanot Arali, a seasoned pharmaceutical professional with extensive experience in GMP audits, quality assurance, and regulatory compliance, holds a strong educational background in pharmacy, with expertise in multiple languages and skills.
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Location
Pune, Maharashtra, India, IN
Languages
  • English Full professional proficiency
  • Hindi Native or bilingual proficiency
  • Punjabi Native or bilingual proficiency
  • Marathi Limited working proficiency
  • Kannada Elementary proficiency
Skills
  • Gmp
  • Regulatory Affairs
  • Quality System
  • Fda
  • Quality Assurance
  • Show all
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Bio

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Credentials

  • IRCA UK certified QMS - Lead Auditor
    SGS
    Sep, 2017
    - Apr, 2026
  • Certified as an Associate Trainer (AT) by the Certification body of the International Board of Certified Trainers
    International Board of Certified Trainers (IBCT)
    Feb, 2012
    - Apr, 2026
  • Competent Technical Person
    FDA India
    Jul, 2005
    - Apr, 2026
  • Registered Pharmacist
    Maharashtra State Pharmacy Council
    Jan, 2005
    - Apr, 2026
  • Competent Technical Person
    Drug Control department, FDA Bangalore, Karnataka India
    Apr, 1995
    - Apr, 2026
  • Certificate of Membership (Outreach)
    Society of Quality Assurance
    Feb, 2024
    - Apr, 2026

Experience

  • FDAQRC
    • Texas, United States
    • Independent Consultant
      • May 2023 - Present
      • Texas, United States

  • Idorsia Pharmaceuticals Ltd
    • Allschwil, Basel-Country, Switzerland
    • GMP Auditor and Compliance Principal Consultant
      • Jan 2021 - Present
      • Allschwil, Basel-Country, Switzerland

      Performing CGMP audits in India on behalf of Idorsia Pharmaceuticals Ltd., a Swiss company having a base in Allschwil, Switzerland.

  • Venus GMP Consultancy
    • Pune, Maharashtra, India
    • Pharmaceutical Quality/GMP Compliance Advisor and Auditor
      • Jan 2011 - Present
      • Pune, Maharashtra, India

      I am performing third party cGMP audits of manufacturer's of API, Veterinary API, Formulations, Excipients, Dietary supplements, Nutraceutical manufacturers, Herbal Medicinal substances and products, Fine chemicals and Specialty chemicals (for Pharma industry) on behalf of European (EU), US and Australia - Newzealand clients and also for Indian Pharmaceutical Manufacturers. Also providing consultancy to Animal Feed supplement/additive manufacturers.Also conducting cGMP trainings as per ICH Q7, WHO GMP, Schedule M, USFDA - 21 CFR Parts 210 and 211 regulations.

  • US Based Consulting (Confidential)
    • Associate - Independent Contractor
      • Mar 2021 - Mar 2024

  • Michaels and Associates
    • Union City, California, United States
    • Senior Associate - GMP
      • Mar 2019 - Oct 2023
      • Union City, California, United States

      Performing third party CGMP audits of Contract Research Organization (CRO) developing and manufacturing Drug Substance and Drug Products for Clinical Supplies to the US market on behalf of Michaels and Associates consulting, having a base in San Francisco Bay Area.

  • PQE Group
    • Italy
    • Business Consulting and Services
    • 700 & Above Employee
    • GMP/GDP Auditor and Compliance Principal Consultant (Compliance Advisor and Auditor)
      • Mar 2020 - Jun 2021

      Worked as a third party GMP Auditor and Compliance Principal Consultant and Compliance Advisor with PQE group, Regello, Florence Italy, a global service provider for life science industry.

    • GMP/GDP Auditor and Compliance Executive Consultant
      • Oct 2018 - Feb 2020

  • Ceva Polchem Private Limited
    • Pune Area, India
    • Technical Consultant
      • Sep 2014 - Dec 2015
      • Pune Area, India

  • Murli Krishna Pharma Pvt. Ltd.
    • Ranjangaon, Pune Area, India
    • Deputy General Manager, Quality Assurance
      • Jul 2007 - Oct 2010
      • Ranjangaon, Pune Area, India

  • Emcure Pharmaceuticals Limited
    • Pune Area, India
    • Quality Assurance Manager
      • Jul 2005 - Jun 2007
      • Pune Area, India

  • SUN PHARMA
    • Dadra and Nagar Haveli, India
    • Quality Assurance Executive
      • May 2003 - Jul 2004
      • Dadra and Nagar Haveli, India

  • MICRONOVA PHARMACEUTICALS
    • Bengaluru, Karnataka, India
    • Executive - Production (Tablets and Capsule section)
      • Jun 1996 - May 1999
      • Bengaluru, Karnataka, India

  • Pharmed Limited, Bangalore
    • Bengaluru, Karnataka, India
    • Production Pharmacist (Tablet section)
      • Jul 1994 - Jun 1996
      • Bengaluru, Karnataka, India

  • Emcure Pharmaceuticals Limited
    • Pune Area, India
    • Junior Pharmacist - Quality Assurance and Manufacturing
      • Jul 1992 - Jun 1994
      • Pune Area, India

      In-process QA and quality monitoring of OSD, oral liquids and external preparations. Manufacturing of Ointments, Creams, External powders, solutions, ear drops of various MNCs and maintenance of related GMP documentation.

Education

  • Govt. College of Pharmacy, KARAD
    Diploma in Pharmacy, Pharmaceutical sciences
  • Shivaji University
    Bachelor of Pharmacy, Pharmaceutical sciences

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