Resumes
Resumes
Milon Shah Boston, MA
View pageWork:
Academic Papers & Presentations
Sep 2010 to Nov 2010
Swiss Pharma Pvt. Ltd
Ahmedabad, Gujarat
Jun 2009 to Aug 2009
Quality Assurance Intern
Zydus Cadila Health Care Pvt. Ltd
Ahmedabad, Gujarat
Jun 2008 to Aug 2008
F&D Intern
Sep 2010 to Nov 2010
Swiss Pharma Pvt. Ltd
Ahmedabad, Gujarat
Jun 2009 to Aug 2009
Quality Assurance Intern
Zydus Cadila Health Care Pvt. Ltd
Ahmedabad, Gujarat
Jun 2008 to Aug 2008
F&D Intern
Education:
Nirma University of Science & Technology
Ahmedabad, Gujarat
May 2009
Bachelor of Pharmacy in Pharmacology
College of Professional Studies, Northeastern University
Boston, MA
Master of Science in Regulatory Affairs of drugs
Ahmedabad, Gujarat
May 2009
Bachelor of Pharmacy in Pharmacology
College of Professional Studies, Northeastern University
Boston, MA
Master of Science in Regulatory Affairs of drugs
Skills:
* Accustomed with NDA/BLA, PMA, 510(k) submissions, Device Classification, IND, and Labeling * Acquainted with Drug Master File compilation & Medical Device Reporting, CAPA handling process Understanding of compliance with Quality Systems, cGMPs, GLP, GCP, ISO 13485 & ISO 14971 * Familiarity with Humanitarian Device Exemptions, Orphan Drug Program, Adverse event reporting, Quality audits, Post Marketing Surveillance, FDA, ICH & GHTF Guidelines * Knowledge of 21 CFR Part 50,54, 56, 45 CFR Part 45, tort's law, fundamentals of intellectual property