- Auditing cGMP 21CFR 210,211, cGMP 21CFR 820, and ICH Q7A.
- Consulting for Gap Analysis USFDA and other audits.
- Medical device international consulting.
- Conducting and organizing trainings and seminars related to Pharmaceutical and Medical device industries.
Expert Witness Experience
- Compiling the U.S. norms for a warehouse located in Bhiwandi, India
- Consulting of Pharma Company for facing USFDA Audits.
Undisclosed Company, Independent Auditor, 2010 - Present
- cGMP auditor, auditing all facets of the pharmaceutical industry: CGMP (21CFR 210,211, 21CFR 820) ICH Q7A; TQM, qualification; validation; mission, vision and values statements; general policies; standard operating procedures ("SOPs"); design, development and validation of test methods, equipment, processes, and supplies; scheduling; staffing and training; materials definition; methods; and systems management.
Undisclosed Company, Owner and Lead Auditor, 2009 - Present
- GMP audits, QA and regulatory documentation for the pharmaceutical and medical device industry and specifically quality management systems.
- Compliance and conduct Mock Audits for USFDA, EUGMP and all other MOH, performing GMP audits on behalf of certification bodies in U.S. and other countries.
- GAP analysis audits, executing audits, organize training and seminars related to pharmaceutical and medical device industries.
- Third Party Audits for pharmaceutical and medical devices (ISO13485) manufacturers, worldwide.
- For major business; advising on compliance with cGMP, conducting mock audits for U.S., EDQM and other authorities.
- Preparing DMF/CTDs for new pharmaceuticals, quality assurance documentations, and third party audits.
- Technical file building for medical devices.
Interactive Consulting Associates, Walchwil, Switzerland, Operations Manager, 2009 - 2008
- Manager on site in India, planning audits, and preparation of seminars.
Charak Pharma Pvt Ltd, Mumbai, India, 2008 - 2006
- Quality assurance and regulatory affairs.
Mehta Pharmaceuticals, Mumbai, India, 2006 - 2004
- Responsible for registration documentation and quality management systems, responsibility to maintaining those systems.
Cipla Ltd, Patalganga, India, 2003 - 2004
- Responsible for registration documentation, describing production processes, in-process controls and validation.
- Quality management systems implementation with responsibility to maintaining the systems affecting APIs and drug products.
Providing seminars and training courses in the following subject matters:
- EU Regulations and EU GMP
- EU Regulations concerning Medical Devices
- ICH Q9 Quality Risk Management
- EU Regulations concerning Pharmaceuticals
- Gateway to the European and U.S. Pharmaceutical Market
- Good Auditing Practices for EU Notified Body Audits
- European Regulatory Affairs
Honors & Publications
- Certified Lead Auditor ISO 13485 - British Standard Institution, UK
- MDD, CE Mark, ISO 13485 detailed training - CEpartner4U (Implementation of Quality Systems)
- Certified Intellectual Property World Intellectual Property Organization (WIPO)
- Quality Assurance and QS9000, NILEM, Chennai, India-Diploma
- Drug Regulatory Affairs, IPER Pune, India-Diploma
- Professional Engineer-P.E.
Academic and Professional Affiliations
- American Society for Quality-Member
- English-Fluent (conversation writing and reading)
- German - Level 1
- Local languages: Hindi, Marathi, Gujrathi
- MBA International Business Management, National Academy, Mumbai, India
- BSc. Chemistry, Shridhar University, Rajasthan, India