Sunitha Singh Email & Phone Number

Presently working with Emergo by UL India consulting Pvt Ltd, Hyderabad as Regulatory manager.#Experience-I: Regulatory consultant in M/s. Emergo by UL (India) consulting Pvt Ltd, HYD(since Oct, 2012).Roles & Responsibilities:Dossier preparation of Medical Device and IVD Kits for Import License (MD-15)Dossier preparation of Medical Device and IVD Kits for New Drug approval certificate Device assessment .Quality check of the technical dossiers of Medical Device and IVD.Review of and assist in deliver of the technical presentation of the Medical Devices at CDSCO office.Review of and assist in deliver of the technical presentation of the Medical Devices at CDSCO office for the SEC meetings. Submission and Follow up at CDSCO office of Import license, Test License ,NOC etc of Medical Devices and IVD. Review of NOC applications and other miscellaneous work assigned.#Experience-II: Technical Data Associate in Medical Device Division with CDSCO,New Delhi.(Jan 2010-Sep 2012).Review of Import License application (IVD Kits both Notified and Non-notified).Review of Test License application(IVD Kits both notified and Non-notified).Review of Registration certificate application (Notified IVD Kits).Review of NOC applications and other miscellaneous work assigned. #Experience-III:Worked as Quality Control (Asst Mngr) with SD BIO STANDARD PVT. LTD., Gurgaon (Nov’2006- April’2008)-SD Bio Standard.•Handling a team of five people motivating them to maintain the overall quality of the products.•SOP preparation, analyzing the tests performed and releasing the kits, maintenance of the instrument records.• Serum Control panel validation, Evaluation of the competitor kits and Training. During my tenure in SD Bio Standard I have completed an ISO 9001 Lead auditor course from BSI#Experience-IV:Worked for J MITRA & CO. LTD., New Delhi. (May’2001- Oct’ 2006) I worked as an approved Analytical Chemist in the Quality Control Department of Immunodiagnostic division in J.Mitra & Co. Ltd., New Delhi.(From 2001 to 2005). Worked as Quality Control In-charge (April ’2005- June ’2006)•Testing of Rapid kits, Elisa kits either for raw material,Inprocess or finished product.•Preparation of SOP’s.•Real time of accelerated stability studies.• valuation of competitor kits.•Training Sales and Marketing team.•Calibration of instruments.#Experience-V:Worked for UNIQUE BIOTECH PVT. LTD., Hyderabad.•One year of working experience at Unique Biotech Pvt. Ltd. as Senior MicrobiologistInoculum preparation,In process testing of product,Finished product testing.

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  Mjhs,Hyderabad

  M.Sc(Biotechnology) From Guru Ghasidas University, Bilaspur (M.P) In 1999.