CURRICULUM VITAE :
Miss. DESAI BHAKTI RAJENDRA
E-mail : bhaktid7394 AT gmail.com
M. Pharm (Quality Assurance)
Junior Officer - Regulatory Affairs
OBJECTIVE :
“To obtain a rewarding position in the field of pharmaceutical educational society and coordinate with a team of highly experienced professionals for my personal as well as corporate growth”.
PROFILE SUMMARY :
1. Preparation of dossiers for Pharmaceuticals for US and Europe markets.
2. Registration of dossiers for Pharmaceuticals for US and Europe markets.
PROFESSIONAL EXPERIENCE :
1. Research Trainee (4 month) in Analytical Development Laboratories (ADL) at Cipla R & D center, Vikroli, Mumbai.
2. Internship (6 months) in Regulatory Affairs at Cipla R & D center, Vikhroli, Mumbai.
3. Presently working in Regulatory Affairs- Junior Officer (US & EU Market) at Inventia Healthcare Limited, Wagle Industrial Estate, Thane, from 16th August 2018 to till date.
AREA OF INTEREST :
1. Drug Regulatory affairs.
JOB RESPONSIBILITY :
At Inventia Healthcare Limited :
** Preparation/Review of Pack Insert& Labelling Information w.r.t Deficiency Letter
** Preparation/Review of Annotated Comparison
** Preparation of single pack insert (SPL), Comparison of Proposed Vs Innovator pack insert, weekly Checking of pack insert /Labelling Updation through Drugs AT FDA or Daily Med
** Filling of FDA Form 356h
** Knowledge of PDF properties (Viz. reduce size, bookmark, hyperlink, set destination)
** Review of document required for Regulatory agencies (Viz. Analytical reports, Process Validation reports, Process validation Protocol, Stability data, Batch Manufacturing Record, Batch Packaging Record, COA, Pharmaceutical development Report)
** Coordination with other departments like ADL, FD, QA, Plant & Project Managements for various regulatory documents required for dossier submission.
** Maintain the regulatory submission lifecycle including original submissions, amendments.
** Review; Compilation and submission of Dossier (ANDA) of US & EU MARKET as per e-CTD through Pharma ready Software.
** Typing of In-process Parameters For exhibit batches and proposed commercial batches according to the BMR and specifications.
** Preparation/Review of dossiers as per current guidelines of the respective regulatory authorities.
** Review/Approval of Finished Product specification and Analytical Procedures (MOA), API specification and MOA, Excipient Specification and MOA, In-process Specification and MOA w.r.t General Information (GI)- Revision History and Change control process (CCP) through Document Managements System (DMS) (Educe)
** Review/Approval of BMR and BPR w.r.t GI and CCP through DMS (Educe)
** Preparation of Annual Product Reports (APR) for US Market.
EDUCATIONAL QUALIFICATION :
** M.
Pharm. (QA) Dr. D. Y. Patil College of Pharmacy, Akurdi, Pune. Savitribai Phule Pune University 2018 74.44% Grade- O
** B. Pharm. Sharadchandra Pawar College of Pharmacy, Otur, Pune. Savitribai Phule Pune University 2015 71.59%
** HSC St. Lawrence Junior College of Science & Commerce, Mumbai University 2012 64%
** SSC Bhagavati Vidyalaya, Mumbai University 2010 73.82%
PROJECT UNDERTAKEN :
B.Pharm :
“ Synthesis and Anti-microbial Evaluation of Novel 2,3-disubstituted Quinazoline-4-ones". Under the guidance of Asst. Professor Mr. S.L. Harer, Sharadchandra Pawar College of Pharmacy, Otur, Pune.
“ Review on HIV/AIDS, Women and Child Welfare”. Under the guidance of Asst. Professor Mr. V.S. Shende, Sharad ChandraPawar College of Pharmacy, Otur, Pune.
M.Pharm :
1. “Effect of Electromagnetic Radiations using Mobile Phones on Stability of Paracetamol tablet”. Under the guidance of Mr. M.T Mohite, Dr. D. Y. Patil College of Pharmacy, Akurdi, Pune-44.
2. “A QbD Approach : Stability Indicating HPLC method Development and Validation for Estimation of Anti- Epileptic Drug” done at Cipla R & D center, Vikroli, Mumbai.
PAPERS PUBLISHED :
1. Role and Overview of Drug Regulatory Affairs in Pharmaceutical Industry and Implementation of CTD and eCTD (Electronic Common Technical Document) and Drug Approval Process.
2. Pharmaceutical Impurities and Development of Stability Indicating Method (SIM).
CONFERENCE / SEMINAR / WORKSHOP ATTENDED :
** I have Attended the Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research organized one day Workshop on “Advances in HPTLC Techniques” in association with Anchrom Enterprises, Mumbai conducted on 29th September 2016 as a Delegate.
** I have Attended the Savitribai Phule Pune University sponsored two days National Conference on “Emerging Trends in Drug Delivery System” Conducted on 12th and 13th February 2016 as a Delegate.
** Participated in Poster Presentation Competition on “Synthesis and Anti-Microbial Evaluation of Novel 2,3-disubstituted Quinazoline-4-ones” organized by Amrutvahini College of Pharmacy, Sangamner, Pune conducted on 12th Feb 2016.
OTHER ACTIVITIES :
** Awarded as First Ranker in Final Year B-pharm at SPCOP College, Pune.
** Participated and won prizes/certificates in sports and cultural events in annual day function held at SPCOP college.
STRENGTH :
** Co-Operative.
** Hard Working and willingness to work.
** Enthusiastic
** Quick learning ability.
** Dedicated towards work.
PERSONAL PROFILE :
Date of Birth : 07.03.1994
DECLARATION :
I hereby declare that the above-mentioned information is true and to the best of my knowledge.
DATE :
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