Quality Assurance Development
Resume:
Curriculum Vitae
SHRIKRUSHNA DIGAMBAR PATIL
Current Address:-
Near Shriram Jewelers, Navghar Road,
Bhayander (E), Mumbai 401105
Cell No.:+91-997******* Email Id: *******.*******@*****.***
Carrier Objective:
To work in a challenging atmosphere that provides me ample opportunity for
learning, growth and to work for achieving organizational goals. I believe in the magic of
teamwork and I wish to give my best to the organization for which I work.
Work Area:
Regulatory Affairs Department.
Educational Qualification:
M.pharm in (Quality Assurance Techniques) completed from Padm. Dr. D. Y.
Patil Institute of pharmaceutical sciences and research, Pimpri, University of Pune.
Examination University/Board Year of Passing Percentage
M.Pharm
Pune 2011 65.07%
(Quality Assurance )
B.Pharm NMU Jalgaon 2009 61.58%
H.S.C Amaravati 2004 60.17%
Current Job:
Officer Regulatory Affairs for US Market in Sidmak Laboratories (India) Pvt.
Ltd. in Regulatory Affairs Department from Nov 2011 to till date.
Experience:
ANDA Compilation and Submission in eCTD format for US Market.
Compilation of Module 1, 2, 3 and 5.
Format specification of CTD, eCTD.
Responding to the CMC deficiencies.
Assisting in Internal/Document audits
Review of Master and Executed Production and Packaging Records.
Review of Product Development Reports and Overall Development Reports.
Review of Process Validation Protocol and Reports.
Review of Method Validation Protocol and Reports.
Review of Stability Study Protocol and Reports.
Review of Technology Transfer Documents.
Review of Proposed bottle label & Pack leaflet.
Curriculum Vitae
Knowledge of Quality by Design (QbD) and Analytical Methods
Take active part in Pharmaceutical Quality System for Change Management System
throughout the Product Lifecycle.
Well knowledge about ICH guidelines related to Quality and Multidisciplinary.
Coordination with R&D, QA, QC, and Production for regulatory requirements for
dossier submission and approval.
M Pharm Project:
Title: “Development and Validation of Chromatographic and Spectrophotometric
methods for the analysis of Metformin hydrochloride and Nateglinide in
multicomponent formulation”
Research Papers Published:
“Stability-Indicating HPTLC Method for Simultaneous Determination of Nateglinide
and Metformin Hydrochloride from Pharmaceutical dosage form”
Status: Published in Saudi Pharmaceutical Journal from (Elsevier)
doi:10.1016/j.jsps.2011.06.005.
“Stability-Indicating RP-HPLC Method for Determination of Metformin
Hydrochloride and Natglinide in Bulk and Tablet Formulations”
Status: Published in the Current Pharmaceutical Analysis from (Bentham Science
Publishers) ISSN: 1573-4129, Volume 8, Issue 4, pp: 381-388.
“Simultaneous spectrophotometric estimations of Nateglinide and Metformin
hydrochloride in pharmaceutical formulation”
Status: Published in Der Pharma Chemica, 2011, 3(3):271-276.
“Estimation of Nateglinide and Metformin Hydrochloride in Tablet Dosage form by
Spectrophotometric Methods”
Status: Published in Journal of Pharmaceutical Research July 2011 issue.
Poster Presentation:
“Stability Indicating HPTLC Method for the Simultaneous Determination of
Amlodipine Besylate and Telmisartan from Tablet Dosage Form” at “Anant Pharma
Poster Presentation Competition” (National level)
Other Persuits:
Attended IPC 2007, Mumbai.
One Month Industrial Training in Ajintha Haffkine, Jalgaon.
Certificate:
Certificate received for “Quality by Design (QbD) and Analytical Methods” from
NetZealous, DBA Global Compliance Panel, USA.
Certificate received for completing in "General Course on Intellectual Property"
from the Distance Learning Section at the WIPO Academy.
Curriculum Vitae
Instruments Handled:
HPLC (Lachrom HPLC System) (Merck Hitachi)
HPTLC (Cammag)
UV- Spectrophometer (Shimadzu-1700)
FT-IR (Shimadzu model 8400S)
Dissolution Test Apparatus (Electrolab)
Computer Proficiency:
Microsoft Word, PowerPoint, Excel, Outlook, Microsoft Paint, Acrobat Professional,
Operating Systems: Windows 6.1, Windows 98/2000 / XP Professional/ Windows 7
Personal Details:
Date of birth: 15 March 1986
Gender: Male
Marital status: Single.
Nationality:-Indian
Languages known: English, Hindi, Marathi
Declaration:
I hereby declare that all the statements made in this resume are true and complete to the best
of my knowledge and belief.
Yours sincerely,
Shrikrushna D. Patil
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