Pharmaceutical GMP Auditor and GAP Analysis Consultant

Expertise

• 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.

Experience

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

Quality Assurance

• 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.

Educator

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

Credentials

• 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

License

• Professional Engineer-P.E.

Academic and Professional Affiliations

• American Society for Quality-Member

Languages

• English-Fluent (conversation writing and reading)
• German - Level 1
• Local languages: Hindi, Marathi, Gujrathi

Education

• MBA International Business Management, National Academy, Mumbai, India
• BSc. Chemistry, Shridhar University, Rajasthan, India