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[QUOTE=Guest-IJT;109981][b]Name [/b]: Kumudini Phapale [b]Email [/b]: kumudini.123.u AT gmail.com [b]Designation / Skillset[/b] : Regulatory Affairs Cover Letter To, HR, [b]Subject [/b]: Application for a post of Regulatory Affairs /QA Dear Sir, I would like to introduce myself as Kumudini Phapale, I wish to apply for a suitable position in Regulatory Affairs based on scientific knowledge, and having knowledge of ICH, CFR GUIDELINES, Documentation in Regulatory Affairs like DMF, CTD, ACTD and Clinical Research. I possess Bachelor of Science (Biotechnology) & basic diploma in clinical research and also did post graduation in drug regulatory affairs (PGDRA). Having 3 months experience as trainee in QA/QC and production at Varun Medico Pvt. Ltd. And 6 months experience in Regulatory as a Trainee in Perfect Pharmaceutical Consultancy Services. With utmost respect to values, I promise to serve your organization with integrity, through innovation and by applying thought, day after day. Sincerity, commitment, honesty and best for learning and hard work will be my virtues for the Organization. I am attaching my updated CV for your kind perusal. Looking forward for your favorable response, thanking you in anticipation Thanks and Regards Kumudini Phapale [u][b]Resume[/b][/u] : [b]Objective [/b]: Seeking to be a part of an internationally recognized progressive organization that offers scope for boosting my knowledge, research and management skills in accordance with the latest trends [b]Area of Interest [/b]: Drug Regulatory Affairs/QA/QC [b]Professional Exposure [/b]: Completed 6 months internship at Perfect Pharmaceutical Consultancy Services, Pune in Regulatory Affairs. [b]Projects Handled [/b]: Compilation of QOS, Module 3 as per ICH CTD guidelines. [b]Education [/b]: Course College/University Year Passed Advanced Post Graduation Diploma in Drug Regulatory Affairs Global institute of regulatory affairs (GIRA) Institute, Pune 2011 Basic Diploma Clinical research Management & Regulatory Affairs Haffkine Institute for Training Research & Testing, parel, Mumbai. 2010 BSc. Biotechnology Mumbai University 2010 [b]Projects During PGDRA [/b]: - Project on Common Technical Document (CTD) (quality module) to acquire marketing authorization in ICH countries for Terbinafine Hydrochloride 250 mg Tablet. Projects during basic diploma in clinical research and regulatory affairs - Project on Committee for Proprietary Medicinal Product (CPMP) to get marketing authorization for TAMIFLU. [b]Regulatory Skills [/b]: - Knowledge of DMF, CTD Module 3 for ANDA and MAA for EU markets through different routes of filing CP, MRP, DCP, National and for US market. - Knowledge of Hatch Waxman Act, Schedule Y, Clinical Research. - Knowledge about the Requirement of ACTD dossier to get marketing authorization in ASEAN countries. - Knowledge about Basic requirements for Dossiers preparation for Marketing Authorisation in Row Market. [b]In-plant Training [/b]: Completed 2 months inplant training at Varun Medico Pvt. Ltd., at Rabale, New Mumbai in Production, QA & QC and was involved in routine activities of Production, QA & QC as mentioned below- [b]Quality Control/ Quality Assurance [/b]: [b]A. Hands-on experience of using instruments during training in Quality Control Department [/b]: during routine analysis like L.O.D. Analysis, Weight Variation, TLC (Thin Layer chromatography) and Karl Fischer Auto Titrator, UV-Spectrophotometer, IR moisture balance, Polarimeter, Pycnometer, pH meter, Moisture Balance (IR), Melting Point Apparatus, Dissolution Test Apparatus, Disintegration Test Apparatus, Friability Test Apparatus, Leak Test Apparatus.. B. Maintenance of Quality Control Record in compliance with WHO-GMP and D and C Act, and their Documentation (CoA, MOA, STP, BMR, SOP). C. Testing of raw materials, packing materials and finished products (Tablets) as single & multi ingredients as per Pharmacopoeia. D. IPQC (In-Process Quality Control) of finished products during manufacturing. E. Product Stability Data Preparation. [b]Manufacturing and Packing [/b]: - Manufacturing of different type of oral solid doses form like tablets (coated and uncoated) and powder with the equipment used in Granulation, Compression, Coating, and Packing. [b]Conferences and Workshop Attended [/b]: [b]- BioPharma Institute Programme GMP [/b]: Documentation and Record Keeping for Good Manufacturing Practices (An Abridged Course). - Conference on IDMA-APA IPC 2010 Thirteenth Pharmaceutical Analysts convention at Hotel Hyatt Regency, Andheri, Mumbai. - Workshop on Drug Regulatory Affairs QA/QC by Asian Institute of Health Sciences, Mumbai. - Workshop on ICH GCP and pharmacovigilance by Asian Institute of Health Sciences, Mumbai. - Workshop on CDM and Medical writing by Asian Institute of Health Sciences, Mumbai. - Seminar on Regulatory Affairs by VPM’s Advance Study Centre, Thane. Computer Expertise - MSCIT in Computers from Govt. Of India - Data mining on RA using internet, HTML, XML [b]References [/b]: Mr. Vishweshwar L. Sangmuly Mr. Sanjiv Kumar (Director (Technical)) at Regulatory Affairs Manager at Perfect Pharmaceutical Consultants Services. Alkems Laboratories Pvt. Ltd. ------------------------------------------------------- [b]More Information about this submission and submitter [/b]:- ___________________________________________________ [b]Submission ID [/b]: 4212027 [b]Date & Time [/b]: 4th Jun 2011 10:00 PM (UTC) [b]IP Address [/b]: 120.61.11.48 [b]Browser Info [/b]: Mozilla/5.0 (Windows NT 5.1; rv:2.0.1) Gecko/20100101 Firefox/4.0.1 Predicted Country : India[/QUOTE]
