Asia - India Specific Pharmacist in Regulatory Requirements; Clinical Trials, Biologicals, Pilot Plant and Pharma Analysis

Technical Consultant #2015


Expertise

  • Diverse experience in pharmaceutical regulatory affairs at national and international levels.
  • Current pharmaceutical regulations in India with major regulatory authorities.
  • Acquired training in international forums by (WHO), World Health Organization and USFDA.
  • Working at apex drug regulatory body in India.
  • Inspection of clinical trials.
  • Sourcing pharmaceutical Information.

Experience

Undisclosed Company, 2003 - Present

Senior Technical Assistant/Technical Officer and Assistant Drugs Controller

  • Reviewed critically and submitted technical files pertaining to import and export of pharmaceuticals, new drugs, therapeutic proteins and medical devices.
  • In a multi-tasking environment, responsible for technically reviewing environment for issuing various regulatory approvals and licenses, 'No Objection Certificates' and applications pertaining to clinical trials, marketing authorizations, post marketing surveillance studies of recombinant - DNA therapeutic proteins.

Government College of Pharmacy, Maharashtra, India, Lecturer in Pharmacy, 1997 - 2000

Educator

  • At various locations, taught undergraduate courses in Organic Chemistry, Medicinal Chemistry, General Pharmacy as theory and practical sessions.
  • Participated in development of departmental plans, policies and technical research projects.

Wockhardt Pharmaceuticals Limited, Aurangabad, Maharashtra, India, 1992 - 1997

Laboratory Quality Assurance Pharmacist

  • Analyzed finished products and raw materials by chemical and instrumental methods (primarily large volume parenterals).
  • Analyzed samples as per official as well as in house specifications.
  • Recorded the analytical results in company's standard format.
  • Extensively involved in other quality related activities such as Good Manufacturing Practices (GMP) inspection, documentation and records management, preparation of SOPs and analytical development work.
  • Coordinated with production, quarantine and dispatch sections to ensure quality end product.

Genpharm Inc., Etobicoke, Ontario, Canada, 2000 - 2001

  • Stored, scheduled and reproduced the stability samples.
  • Carried out stability documentation duties.
  • Controlled, recorded lab samples and other technical assistance in a strict GMP environment.

Honors & Publications

Credentials

  • Pharmaceutical Chemistry - Duly Certified after evaluations of credentials by the University of Toronto as to be equivalent to a master degree from a reputed Canadian University.
  • GMP certification conferred by M/S Genepharm Inc , Canada
  • Quality Management Certificate , IIM, Jaipur, India
  • Online certification in Good Clinical Practices conferred by Pharmaceutical School of United Kingdom.

License

  • Pharmacist E

Languages

  • English (very fluent at all levels)
  • Hindi (Very fluent at all levels)

Academic and Professional Affiliations

  • Regulatory World
  • Biotechnology Ireland

Awards

  • Scheme Award conferred by M/S Wockhardt Ltd India

Publications

  • Thesis: Synthesis; Benzamidazole Derivatives - Preliminary Pharmacological Screening.

Education

  • M.S. Pharmacy, Nagpur University, Nagpur, Maharashtra, India
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