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Hyderabad, Telangana, India
... Also includes sales forecasting and analysis on top bio-pharma products, research pipeline, FDA approvals and information on molecules in various clinical phases. Primary Survey: Market survey done in Bangalore and Hyderabad for Sleeve slips in ...
- 2016 Oct 26
Hyderabad, Telangana, India
... Extensive hands on experience and knowledge of Food and Drug Administration (FDA) regulations (particularly 21 CFR Part 11/ 210/ 211/ 820) qualification-testing protocols (IQ, PQ, OQ). . Experience in GxPs (GMP, GCP, GLP). Validation process and QA ...
- 2016 Oct 25
Hyderabad, Telangana, India
... •Validation Deliverables: Validation Master Plan, Summary Report, Test plan, URS, FRS, DS, RTM, DQ, IQ, OQ, PQ protocols in compliance and conformance with FDA, MHRA Regulations. •Experienced in gathering user requirements, analyzing and preparing ...
- 2016 Oct 18
Hyderabad, Telangana, India
... Point, Saponification Value etc., Standardisation of Solutions, Maintaining Experiments & Tests Record Faced internal as well as external audits form different companies & organisations like Castrol, VHB Life Sciences ltd, ISO, WHO GMP and FDA etc. ...
- 2016 Jun 24
Hyderabad, Telangana, 500045, India
... Eudralex 11 IT Documentation FDA Guidelines 21 CFR part11 Regulatory Affairs Statutory Compliance ISO 17025:2005 EDUCATION Bachelor in Pharmacy, Malla Reddy Institute of Pharmaceutical Sciences, India – 2012 TRAININGS ATTENDED 21CFR Part 11. ...
- 2016 May 12
Hyderabad, Telangana, India
... Expertise in all aspects of the Computer Systems Validation Lifecycle for compliance with FDA Regulations. Expertise in Technical Writing of Validation Protocols like Installation Qualification (IQ), Operational Qualification (OQ) and Performance ...
- 2016 Feb 17
Hyderabad, Telangana, 500057, India
... Advanced skills in EDC systems, study hypothesis, well-versed in cGCP and FDA standards and regulations, and knowledgeable in various therapeutic indications. Professional Experience TECHSOL SYSTEMS INDIA PVT. LTD Validation Functional Consultant, E ...
- 2015 Aug 17
Secunderabad, Telangana, 500056, India
... in M/s Gland Pharma Ltd., Dundigal, Hyderabad an ISO 9001 certified company and pioneer in Heparin Technology and also an USA FDA approved company as a Jr.Chemist in Quality Control Department for a period of 2 years (Oct 2001 to Feb 2004) *Medical ...
- 2015 May 08
Secunderabad, AP, India
... Information/Data Flow • Change Management • GxP Standards • Process Reengineering/Training • Publishing process • Coordination of FDA inspections • 21 CFR Part 11 compliance activities Pharma Industry – Information Technology: • Front End Reporting, ...
- 2014 Mar 25
Hyderabad, AP, India
... Reg No: KCS/IDCRR/B03/0022 4NIH CLINICAL CENTER National Institute of Health Clinical Research 5INTRODUCTION TO CLINICAL DRUG DEVELOPMENT PROCESS: ICH/FDA Good Clinical Practice For Clinical Trial Sites * SCEPTER TM * April 2010 6CLINICAL OPERATIONS ...
- 2014 Mar 16