|Address : Phone :
***, ********** *****,
**, ********* *******, (M): 942*******
Ms. Jugnu M. Shah
Objective : To build a career in Quality Assurance/International Drug Regulatory Affairs in a pharmaceutical industry.
Bachelor of Pharmacy, 1986 – 1991, 58.3%, M.S.University, Vadodara)
H.S.C. (Eng. Med.), 1985 – 1986, 65.0 %
S.S.C. (Eng. Med.), 1983 – 1984, 75.0 %
Experience : Total Work experience of 10 years in QC/QA/DRA in a Pharmaceutical industry.
Company : Ronak Exim Pvt. Ltd.(100% EOU)
Designation : Manager– Regulatory Affairs
Duration : July 2008 – Contd.
Job Profile : 1. To ensure the filing of required regulatory documents on time as per regulatory norms, take active participation from start of the project and give Regulatory strategy inputs to the team.
2.. Liaise with Regulatory agencies, partners, customers, agents.
3. Lead a team dedicated for a project and be a part of any Regulatory inspection.
4. Play an important role in any decision making.
5. Review of Dossiers, regulatory documents, response to deficiencies and guide team members.
6. Ensuring Good Regulatory Practices are followed within the team and also proper training is provided amongst the team members.
7. Perform Gap analysis
8. Review of technical documents viz.Validation Reports like Analytical Method Validation Reports, Process Validation reports, and Batch Manufacturing Records, Change Control, Deviation etc. for regulatory compliance according to the requirement of ROW regulated markets.
9. Revising all the technical documents like key QA-SOPs, Master Formula Cards, Batch Manufacturing Records etc. as per the requirements of ROW regulated markets.
10.Responding various queries related to requirements of Technical Data from various regulatory authorities and updating all the documents for the purpose of regulatory compliance according to the requirement of ROW highly regulated markets.
Company : Gujarat Liqui Pharmacaps Pvt. Ltd.(100% EOU)
Designation : Assistant Manager–Quality Assurance and Regulatory Affairs
Duration : October 2007 – June 2008
Job Profile : 1. Preparation, Updation and Review of all technical documents like key QA SOPs, Process validation reports, Cleaning Validation reports, Master Validation Plan etc. for regulatory compliance as per the requirements of semi-regulated ROW markets.
2. Revising all the technical documents like key QA-SOPs, Master Formula Cards, Batch Manufacturing Records , Change control, Deviation etc.for the purpose of regulatory compliance as per the requirements of semi-regulated ROW markets.
3. Responding to various queries related to requirements of Technical Data from various regulatory authorities and updating all the documents for regulatory compliance
Company : Cadila Healthcare Ltd. Ahmedabad.
Designation : Sr. Executive – Quality Assurance [Document Control]
Duration : September 2000 – March 2001
Job Profile : 1. Issuance and control of all technical documents like QA-SOPs, Finished product specifications, Validation protocols and reports, Master Formula Cards, Batch Manufacturing Records etc.
2. Revising all the technical documents like Key QA-SOPs, Finished Product Specifications, Master Formula Cards etc. as per the requirements of highly regulated markets.
3. Active participation in establishing Batch Record Issuance System as per TGA, USFDA etc
Company : Cadila Pharmaceuticals Ltd. Ahmedabad.
Designation : Executive – Regulatory Affairs (Formulation & Development Dept, R & D)
Duration : April 1999 – August 2000
Job Profile : 1. New product application, New product co-ordination, Technical support to Export regulatory affairs, USFDA Team member.
2. ANDA filing documentation for USFDA approval.
Company : Alembic Ltd. Vadodara
Designation : Officer Exports – (Regulatory Affairs- Technical Services)
Duration : April 1997 – March 1999
Job Profile : Preparation of Technical Dossiers for Registration of Pharmaceutical products in different countries.
Company : Alferez Pvt. Ltd. Vadodara
Designation : Executive Exports – (Regulatory Affairs- Technical Services)
Duration : July 1996 – March 1997
Job Profile : Preparation of Technical Dossiers for Registration of Pharmaceutical products in different countries; Co-ordination with production, Training of technical supervisors etc.
Company : Astral Pharmaceutical Industries, Vadodara
Designation: Sr. Quality Control Chemist
Duration : October 1992 – July 1994
Job Profile : Physico-chemical analysis of raw material & finished products, Sterility testing, Sampling & GMP documentation.
Additional Professional Activities :
1. Attended various Seminars on Export Regulatory Affairs(organized by Chemexcil),GMP, Future of Pharmaceutical industry in post patent era and NDA & ANDA (organized by IPA & Pharmacy Alumni Association, Vadodara)
2. Attended IV Internatinal Symposium in “Innovations in Pharmaceutical Sciences & Technology” (organized by PERD Centre)
Key Skills :
1. Effective Communication & Presentation skills, Global perspective.
2. Good Documentation skil-Technical/Scientific documentation.
3. Excellent Management skills.
4. Comfortable working as a team leader and effective in team building.
Approved as “Technical staff” in Physico-Chemical Analysis by FDCA, GUJARAT STATE, GANDHINAGAR.
Professional Memberships :
Life member of Indian Pharmaceutical Association and Pharmacy Alumni Association, M.S.U. Vadodara.
Date of Birth : February 16, 1969
Sex : Female
Nationality : Indian
Passport No. : A 97117748
Marital Status : Single
Languages Known : English, Hindi & Gujarati
Interests : Reading, Hiking.
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