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Curriculum Vitae
Post desired: Assistant Manager
Experience Faculty: Quality Control (Pharmaceuticals) - API / Peptide / Cytotoxic API
Qualification
M.Sc. in Biochemistry from Shivaji University, Kolhapur, (M.S.) India
B.Sc. in Chemistry from Shivaji University, Kolhapur, (M.S.) India
Personal Details
Name Mr. Sanjay Narayan Nalage
Date of birth 02 December 1979
Gender Male
Marital status Married
Nationality Indian
Languages known
(Speak, read & write)
Marathi, English, and Hindi.
Address for correspondence Present Address
Sainath Apartment, Flat No.1, Dattanagar.
Gopalwadi road, Back to Sakhare Garej,
Daund, Tal-Daund,
Dist- Pune
State- Maharashtra, India
PIN-413802
Permanent Address
Naikwadi Plot, ring road Barshi
Tal-Barshi ,
Dist- Solapur
PIN-413411
State: Maharashtra (India).
Mobile Phone : 9423765630
Phone No : (02184) 221156
E-mail ID sanjaynalage@yahoo.co.in

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Professional Experience details
Years of experience 13 + years
Current CTC 8.05 Lac per annum
FDA Approval FDA Certification for chemical & instrumental analysis
Handling Quality system LIMS,SAP System
Current Organisation Emcure Pharmaceuticals Limited
Current position Executive Quality Control
Location Plot no.D-24,MIDC,Kurkumbh,
Tal: Daund Dist :Pune
Regulatory Approval USFDA ,WHO,FDA, Various customer Audits
Previous Organisation USV Limited
Working period December- 2002 to July -2011
Location B 1/8,Lote purshuram MIDC,Khed ,
Tal:Khed Dist : Ratnagiri
Regulatory Approval USFDA ,WHO,TGA,FDA, European audit Berlin health
authority, Various customer Audits

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Key Duties and
responsibilities
Oversee the day-to-day QC activities such as - Analysis - Release of Raw
material, packing material, inprocess, intermediate, cleaning and finished
API Products.
Leading and directing 10 member analytical team to deliver.
Execution and monitoring of analytical activities for Stability Studies of API
products. Initiation of stability Study – updation of stability schedule – review
stability study analysis–Data compilation.
Initiation of stability Study – updation of stability schedule – stability chambers
monitoring– Maintenance
Responsible for analytical Work allocation to officers and chemist–Superior
Approval and Usage decision initiation – Registration – Allotment – review-
checking- Approval/Rejection.
Verification of analytical test data and analytical technical reports.
Implementation of cGMP and GLP compliance to analytical activities. Training
to concern staff.
Preparation and revision of SOPs related to QC activities, laboratory
equipment and ensure its implementation.
Preparation and revision of key quality documentation Analytical method
transfer protocol, stability protocol, stability summary reports, product
specification, calibration Schedule for laboratory equipments and its
implementation.
Initiation of Event / OOS / Atypical / Lab Deviation / OOT Results – under
Laboratory investigation, Change control , CAPA and accountable for closure
of documents.
UPLC /HPLC/GC/IC Column Management.
Registration –Assignment-Approval/Rejection-Destruction.
Volumetric solution Management.
Registration –Approval / Rejection- Destruction.
Participation in audit activities, Coordination with Production, QA, ARL Dept.
Promote and enforce the high level compliance and good ethical conduct
throughout the team. Electronic data Evaluation-Audit trial review for Data
integrity.

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Expertise Work Areas
Hands and experience on qualification and calibration of latest instrument in
UPLC, HPLC,IC,UV,FTIR etc.
Analytical method validation (Cleaning)
Analytical method Transfer
Qualification & calibration of instruments ( IQ,OQ,PQ)
Working Standard Preparation
Familiar with troubleshooting related to chromatography
Analytical protocol & raw data work sheet preparation
Handling of new analytical methods and New API Products
Expertise in instruments
Instrument Make
UPLC System Waters Acquity with Empower software
HPLC System
Waters with Empower software
Dionex with chromeleon software
Shimadzu with Empower software
Ion Chromatography Dionex with chromeleon software, Metrohm
UV- VIS Spectrophotometer Shimadzu and Perkin Elmer
FTIR Spectrophotometer Shimadzu
Autotratior Metrohm
Melting point Buchi
Polarimeter Jasco
Karl- fischer Mettler Toledo and Metrohm