• Job Target: Reulatory/QA - Associate/Sp...
• Employment Status: Employed - Will Consider Right Opportunity
• Experience Level: Not Specified
• Seeking: Full-Time
• Industry: Pharmaceutical Resumes

• Salary: 60000 to 90000
• Degree: Not Specified
• Security Clearance: None
• Travel: Light
• Relocate:: No

Objective

PUNAM DESAI 23 Wenonah Avenue; Lake Hiawatha, NJ 07034 862-812-3835 punam_a_desai@yahoo.com QUALIFICATIONS OVERVIEW Diversified 5 years experience in pharmaceutical, nutritional, and academic industries. Good written and verbal communication skills. Demonstrated ability to organize, prioritize assignments, and meet timelines. Highly flexible and adaptable to changing priorities. Knowledge and ability to use computer technology. EDUCATION MS, Analytical Chemistry, Montclair State University, Montclair, NJ 2004 Distinguished Achievement; Placed #1 in the Comprehensive MS, Physical Chemistry, S.G. University, India 2001 (Equivalent to United States M.S Degree granted by World Education Services, NY) BS, Chemistry, S.G. University, India, 1999 PROFESSIONAL DEVELOPMENT RAC (Regulatory Affairs Certified), RAPS, 2008 Building Better Work Relationships: New Techniques for Result-Oriented Communication, 2008 Qualified cGMP Auditor, 2007 Training for Effective Technical Writing, 2005 Trained on Computer based applications, such as Trackwise, Excel, MS Word, Power point, etc. REGULATORY SKILLS AND KNOWLEDGE ï IND, NDA, and ANDA submissions for drugs and biologics according to CFR Title 21 ï Medical device and combination products submissions ï 510(k) and PMA requirements ï Amendments and Supplements ï RX-to-OTC switch and cosmetics products requirements ï Knowledge of CTD/eCTD format ï Advertising, labeling, and promotional labeling requirements according to Federal Trade commission (FTC) and federal food, drug & cosmetic act (FD&C act) PROFESSIONAL EXPERIENCE Barr Pharmaceuticals, Pomona, NY 2005 ñ Present, Analytical Research and Development Chemist-II 2004 ñ 2005, Analytical Research and Development Chemist-I ï Write method validation protocols and reports as well as investigation/deviation reports in GXPharmaÆ - a completely paperless document management system. ï Involved with Regulatory Compliance department about investigation/deviation (CAPA) actions, Non-conformances, further planning, and method validation & submission related activities. ï Write stability reports and comparative reports for submission of ANDA projects. ï Review test method and Quality Overall Summary report (QOS). ï Participate in method transfer and change control activities. ï Audit documents for method validation and process validation, as well as specification sheet for QA-release and stability testing. ï Perform method validations of USP/NF and non-compendial generic pharmaceutical products in accordance with internal Standard Operating Procedures (SOP) and ICH guidelines. ï Interact with the formulation department to develop and evaluate ongoing ANDA projects. ï Work independently and as a team member in the ongoing ANDA projects to develop and evaluate analytical methods. ï Proficient in literature searches to facilitate product development procedures. 2003 ñ 2004, Montclair State University, Montclair, NJ Graduate Assistant Teacher ï Taught laboratory classes; full responsibility for preparation and delivery of lectures, grading reports, quizzes and exams. ï Established lab assignments; performed calculations, solutions and calibration of instruments; provided extra tutoring during office hours. 2002, Garden State Nutritional, Inc., Fairfield, NJ Quality Control Chemist ï Involved in OTC drugs and dietary supplements testing. ï Analyzed herbal, water-soluble and fat-soluble vitamins. AFFILIATION Member of Regulatory Affairs Professionals Society Member of American Chemical Society

Job Target

Reulatory/QA - Associate/Specialist