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Watson Mumbai : Corporate Quality Operations
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[QUOTE=Guest;206553]Ashish R Srivastava [b]E mail [/b]: ashishr_s05 AT rediffmail.com ; ashishr_s07 AT rediffmail.com Curriculum-Vitae [b]Quality Assurance – Documentation & Compliance Experience [/b]: Approx. 07Years CURRICULUM VITAE 1. Objective To work for an organization with strong belief and determination to achieve the desired goal with personal achievement. 2. Professional Background Current Employer Alkem Research Centre, Taloja, Navi Mumbai (M.S.) from 19th Nov.2010 as a Senior Research Scientist – Regulatory Affairs (Document & Audit Compliance). It is a rapidly growing Pharmaceutical Company having WHO (local & Geneva), USFDA approval & MHRA Approval. Previous Employer a. Ipca laboratories Ltd., Ratlam, as a Jr. Officer(QA-IPQA & Documentation Activity) b. Ranbaxy Laboratories Limited, Dewas (M.P.), as a Sr. Officer(QA - Documentation) 3. Work Experience a. Ipca laboratories Ltd. Ratlam from Jul.2005 to Aug.2008 b. Ranbaxy Laboratories Limited, Dewas (M.P.) from Sep.2008 to Nov.2010 4. Current Job Profile - Data Review {Batch Manufacturing and Packing Documents,Specifications,Validation Protocol & Report, Stability Data}for ANDA filing and other document compliance activity for EU, Canada, Australia& US Markets. - Change Control, Deviation, Batch Manufacturing and Packing Documents review &Approval - Familiar with e-CTD and worked in Module-3 - Document compliance for deficiency received from USFDA, Data compilation for Annual reports under supervision. - Review of Technical/Commercial Agreements with the EU and Australia Customers - Handling of Technology Transfer activity with the stakeholders (Plant & Customers) - Actively Co-ordinating with stakeholders for Regulatory Audit Compliance. - Co-ordinating with stakeholders/Various Departments for Documents availability on the stipulated time for regulatory filing 5. Previous Job Profile Ipca Labs Ltd., Ratlam (M.P.) - Involved in the IPQA checks & execution activity of Solid & Liquid Dosage Form Products according to SOP and cGMP practices at shop floor. - Process validation (sampling, monitoring & Protocol Compilation). - Handling of Change Control/Deviation & its closure. - Auditing of Batch Manufacturing and Packing Documentsthoroughly at every stage during in process checks - Master Manufacturing Document (MMD) Review and review of Batch Manufacturing & Packing Records - Batch Manufacturing and Packing records Issuance; Controlling of SOP and relevant formats/documents - Annual Product Review Compilation - Documents review of Raw Material/Finished Product/Packing Material related specification against Pharmacopoeia and MMD - Regulatory Follow-ups (Providing the documents/Finished Goods/Packaging Material Samples as per dossier/registration requirement of the respective countries). - SCM Operation (Supply Chain Management) to ensure online documentation of RM/PM/FG materials Ranbaxy Laboratories Limited Dewas (M.P.) - Documentation Control (Change Control, SOP’s, PV Report) - Handling of Change Control & Planned Deviation & its closure - Annual Product Review Compilation - Review of Technical/Commercial Agreements of the various Customers - Training Record Maintenance - Controlling of SOP and relevant formats/documents 6. Qualification - B.Pharma from Rajiv Gandhi University of Health Sciences, Bangalore in year 2005 with 1st Division - D. Pharmacy from Orissa State Board of Pharmacy, Bhubaneswar in Year 2000 with 1st Division 8. Declaration I hereby declare that all the above information is true to the best of my knowledge. [b]Date [/b]: [b]Place [/b]: (ASHISH RANJAN SRIVASTAVA)[/QUOTE]
