Regulatory executive
Posted on: 2011-11-16
CURRICULUM VITAE
Address:
Post-Moholla Patak
Premlata Rani New Basti, Jahangirabad
Mobile: +917307559679 Bulandshaher U.P.
E-mail: [email protected] Pin Code: 202394
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Experience |
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Over all 2+ Year’s Experience in Drug Regulatory Affairs. A Regulatory professional with experience more than 2 years in the reputed pharmaceuticals industries both in factory and corporate level. Dedicated to maintaining quality standards. Able to work on own initiative and as part of a team.
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Professional Qualification |
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Bachelor of Pharmacy from Lloyd Institute of Management & Technology (Greater Noida) approved by Uttar Pradesh Technical University & PCI with Aggregate 70%. |
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Academic Qualification |
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: Matriculation from U.P. Board with 54.6 % in 2002.
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Present employer
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Health Biotech Limited. Chandigarh (Haryana), A WHO-GMP Certified Company from July 2011 to till Date. |
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Designation |
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Executive-RA (Drug Regulatory Affair Department) |
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Past Experience |
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Alchon Parental (India) Limited Bhiwadi (Rajasthan) From August 2010 to June 2011 as an RA Executive. Ahlcon Parenterals (India) Ltd. has achieved the Quality Certification WHO-GMP International and ISO 9001:2008. Manufacturing Intravenous Fluids & Eye/Ear Drops by highly sophisticated Manufacturing process, From – Fill-Seal Tech, having annually strong turnover about 100 crore.
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Gracure Pharmaceticals Limited Bhiwadi (Rajasthan) From Aug 2009 to August 2010 as an RA Executive. A WHO-GMP, EU-GMP and ISO 9001:2004 Certified Company. Gracure Pharmaceuticals Limited has two plants, another one is situated at Nalagarh (H.P.). It has near about 200 crore turnover annually and have well market inEurope and Russian countries. The Gracure Pharmaceuticals Limited is now an EU-GMP certified company having strong market Globally. |
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Summer Training
Job profile |
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Aurochem (I) Pvt. Ltd
Add:B-74, Sector-2 Noida Pin 201301 (India) Duration: 07-06-2008 to 07-07-2008
Handling over all Dossier work and related document as per with CTD and ACTD.
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Preparation of Dossiers as per ACTD , CTD Guidelines & CIS countries Mainly for following countries: -Vietnam, Singapore, Indonesia,Myanmar. -Kenya, Trinidad, Tajikistan, Taiwan, Sudan. -Nigeria, Thailand, Ukraine, Uzbekistan,Tanzania. -Greece, Turkmenistan, Philippines, Mission,Venezuela and South Africa etc. |
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Preparation and review of query (dossier) response. |
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Maintaining Regulatory documents as per the procedure. |
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Reviewing of DMF & Preparation of COPP,FSC, NOC and registration file for New drug
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Instrument Handle |
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Disintegration Apparatus, Friability Test Apparatus, Electronic Balance, Hardness tester, Vernier Caliper. |
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Inspection Phases |
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WHO, GMP and EU-GMP |
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IT Skills |
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MS office, Network Knowledge with Internet. Ms Office-2003-2010 Win98/XP/2000/7
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Personal profile
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Father Name : Shri Rajendra Singh Mother Name : Smt Lajjawati D.O.B : 27th November 1986 Marital status : Unmarried Gender : Female Permanent Add.: Post-Moholla Pathak New Basti Jahangeerabad Bulandshaher U.P. Pin- 202394 |
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Present Salary |
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2.4 Lac per annum CTC |
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Expected salary |
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Negotiable |
I, hereby declare that the above mentioned details are complete & correct to the best of my knowledge.
Date:
Place: (Premlata Rani)