PROFESSIONAL OBJECTIVE :
Seeking a position in Regulatory affairs/ADL were I can utilized my pharmaceutical knowledge, four years of analytical skill as well as two years of quality assurance experience in the best interest of organization.
EXPERIENCE :
TOTAL EXPERIENCE :6.5 Years
Presently working as Research Scientist in QA division of Astron Research Limited Ahmadabad.(Jan`11-Till date)
Worked as Executive-ADL with Zyfine (A Division of Zydus Cadila Healthcare ltd) in Analytical Development lab (Dec`2005-Jan-2011)
Worked as officer-QA with Cipla Pharmaceuticals(Sept`04-Dec`05)
INSTRUMENT HANDLE :
HPLC and Preparative HPLC :-
Waters ,Dionex Ultimate 3000, Schimadzu Class-VP , Agilent 1200 RRLC , Perkin-Elmer
Gas Cromatograph :-Agilent-6890N with HS-GC
Mass/LCMS :Waters and API-2000 series
UV :Schimadzu-1700 Pharmaspec
Polarimeter :Jasco-p-1020
I.R :Perkin Elemer
Autotitrator-PH Meter :Metrohmftware Awareness: Chromeleon,Empower,Anayst,Chemstation,Totalchrome,Class-VP and EZchrome.
JOB PROFILE :
Astron Research Limited :
Planning and Implementation of Analytical method validation as a part of technology transfer from research level to Scale up level at mfg site.
Review of all analytical data as a part of technology transfer document includes AMV, specifications, MOA, COA, MMF and MFC for the batch released.
Impurity profiling, Identification ,characterization and finalization of acceptance criteria as per ICH
Review the specification inline with the respective pharmacopoeia and make the equivalence study
Analytical method transfer from site to site and to make sure that later has ability to implement it and its effectiveness too.
Co ordinate regulatory affair dept for effective filling of different dosage form and resolve there queries with respect to product formulation and analytical method.
Monitoring the stability studies by evaluation of OOS and OOT data for various climatic zones.
Monitoring, review & handling the change control, deviations, incidence report and variations.
Preparation of SOP`s for various departments and effective implementation of same by conducting internal audits.
Maintaining calibration status for all the instruments.
Vendor audit and vendor qualification.
Raw material sampling
Zydus Cadila Healthcare Ltd :
Analytical method development and Validation of same by various analytical techniques.
Responsible for successive method transfer from site to site and preparation of method transfer document.
Isolation, identification and qualification of various impurities with the aid of PREP-HPLC.
Conducting Stability study and investigation of OOS/OOT
Qualification of Standards(Primary/Secondary)
Routine analysis of samples from the F&D inline with specification and MOA
Calibration of all analytical instruments and maintain the calibration schedule of the same
Review and challenging specification and test method.
Analyzed and examine raw material ,API ,return goods, to determine whether they should be release, reprocessed or destroyed.
Responsible for effective SAP implementation at ADL/QC user site.
Responsible for Inventory control in ADL
Maintaining the key spare part for all the analytical instrument
Cipla Pharmaceuticals :
Performed processed validation and cleaning validation
Effective documentation includes preparation of STP, Protocol, FPS and MOA.
Prepare and review of MMF,MPF,BMR,BPR and distribution of same.
Supporting role for PTC cell for dossier filing of various pharmaceutical product.
Ensure that pharmaceutical product is design and develop in away that take account of the requirements of cGMP, and GLP.
Participation in investigation of deviation discrepancies or test failure & Compliant Handling.
Dossier preparation, DMF preparation and preparation of document require for ANDA and product registration cell.
Responsible to arrange the training programs with regards to various cGMP and GLP.
Preparation of training protocol and induction programmers for new employee.
Professional Qualification :
2008-2010 M.PHARM (73.00%) N.C.P.
Nagpur University
2001-2004 B.PHARM (63.00%) V.B.C.P, Amaravati University
Academia :
1999-2001 D.Pharm G.C.P.A , AICTE Mumbai
1998-1999 H.S.Sc S.S.C, Amravati Board
1996-1997 S.S.C N.H.M ,Amravati Board
THESIS :
Method development and validation of Valproic acid and sodium valproate in various pharmaceutical dosage forms.
ACHIVEMENT :
The only employee in History of Zydus Cadila Healthcare Ltd who got the full time sponsorship to proceed the Post graduation (M.Pharmacy) with permission to perform the thesis work at Zyfine only