Experience

Tamilnadu Test House Pvt Ltd

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Managing Director

  • Jul 2016 - Present



Pharma, Food Testing Laboraotry

• Operation Manager

  • Dec 2013 - Jun 2016

  Lab Operation, Quality , Business Development. Lab Operation, Quality , Business Development.



DFE Pharma

• Germany
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Head-QC

  • Aug 2012 - Nov 2013

  Heading the QC team as Manager-QC and supporting the MCC, CMC Production. Currently working on Validations and set up the QC lab with new Instruments/Equipments . Heading the QC team as Manager-QC and supporting the MCC, CMC Production. Currently working on Validations and set up the QC lab with new Instruments/Equipments .



Shasun

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Head-QC

  • Aug 2011 - Aug 2013

  Method development, Assay validation, water validation, Optimization of all the methods, Writing monograph to IP, Implemented the Regulatory system in the Dept. Method development, Assay validation, water validation, Optimization of all the methods, Writing monograph to IP, Implemented the Regulatory system in the Dept.



Shasun Pharmaceuticals Ltd, Cuddalore, Tamilnadu

• Asst.Manager

  • Jul 2010 - Oct 2011

  Section Head-HPLC Section Head-HPLC



TTK-LIG Ltd, R&D Centre

• Asst.Manager

  • Oct 2008 - Mar 2010

  Method development for new projects and validation as per cGMPAnalysis of In process and final bulk samples of Medical devicesDocumentation as per ISO standardsHandling of Instruments like HPLC, GC-MS, AAS, etc.Stability Studies of Drug Substances and Drug Product as per established In-house, USP, Ph/Eur. and BP by HPLC.Experienced on setting up a new analytical laboratory with sophisticated instruments and utilities.Calibration and maintenance of all Analytical Instruments. Method development for new projects and validation as per cGMPAnalysis of In process and final bulk samples of Medical devicesDocumentation as per ISO standardsHandling of Instruments like HPLC, GC-MS, AAS, etc.Stability Studies of Drug Substances and Drug Product as per established In-house, USP, Ph/Eur. and BP by HPLC.Experienced on setting up a new analytical laboratory with sophisticated instruments and utilities.Calibration and maintenance of all Analytical Instruments.



Shasun Reserach and Development Centre

• Officer

  • Dec 2004 - Oct 2008

  Products : Recombinant Streptokinase, Interferon, GCSFJob Responsibilities: HPLC Method Development and validation as per ICH guidelines for analysis of Recombinant Proteins.Peptide Mapping, Analysis of Samples in SEC-HPLC, PREP-HPLC.HPLC Method development to separate the positional isomers of proteins using PREP columns in PREP HPLC.Act as a certified internal Auditor covers ISO and cGMP.Biochemical assays like Bradford, Lowry, SDS PAGE, Endotoxin and Western Blot.Analysis of In-process materials and finished products, all raw materials, as per the validated established methodologies.Raw material analysis and STP writing.Knowledge of analysis in checking specifications, SOP's and other important audit related documents.



JK Pharmachem Ltd

• QA/QC

  • Aug 2002 - Sep 2004

  Job Responsibilities: Analysis of In process and final bulk samples of Pencillin-G and Pencillin-V.Maintenance of all the shift activitiesHandling of Instruments like HPLC, GLC, Colorimeter, etc.Analysis and Certification of Final DrugCalibration and maintenance of all Analytical InstrumentsReceiving and storage of Chemicals, Ensure that all work is accurate, Precise, properly documented and Performed with in GLP guideline Job Responsibilities: Analysis of In process and final bulk samples of Pencillin-G and Pencillin-V.Maintenance of all the shift activitiesHandling of Instruments like HPLC, GLC, Colorimeter, etc.Analysis and Certification of Final DrugCalibration and maintenance of all Analytical InstrumentsReceiving and storage of Chemicals, Ensure that all work is accurate, Precise, properly documented and Performed with in GLP guideline