Summary
Overview
Work History
Skills
Skillhighlights
Academics
Personal Information
Projects
Disclaimer
Timeline
Generic

Sekhar Chandra Mohanty

Computer System validation specialist
Berhampur

Summary

Seeking a challenging career in an organization having the environment that encourages continuous learning and provides exposure of new technologies, so as to achieve professional and personal growth in the field of Life Sciences Technologies and Healthcare sector.

Over 13+ years of experience in Life Science and Health Care Domain as a R&D scientist / Application Specialist / Business Analyst / Validation Lead with Experience in Validating softwares used in Analytical Instruments (CDS) / LIMS / ELN / Medical devices and Lab Instruments in regulated companies in accordance with 21 CFR part 11 and GxP Regulations. 3+ years of experince as On site Compliance Lead for Top pharma major in Tokyo and UK Holding 10 years US business Visa IT-Complaince for SAP S4/HANA implementation projects on Cloud Highly proficient with all the phases of SDLC process, validation methodologies and concepts of qualification protocols (OQ/PQ). Experience in Authoring and Reviewing of validation deliverables required for Greenfield & Brownfield projects as per Lifescience and CSV requirements and industry Standard. Working knowledge of GLP, GCP, GMP and GAMP guidelines. Experience in preparation of SDLC documents,performig GxP Assessment,GAP analysis to ensure they meet GxP and FDA regulations Participated in Developing User Requirement Specifications URS, Functional Requirements Specification FRS.

Overview

17
17
years of professional experience
3
3
Languages

Work History

Onsite Risk and Compliance Lead (IT compliance/Validation)

Accenture solutions PVT LTD
5 2018 - Current
  • Project (SAP S/4 Hana implementation)
  • IT compliance lead for development and implementation of SAP S4 HANA for a reputed Multinational Pharma company
  • Risk assessment, defining validation strategy in align with GAMP 5
  • Author and Review of SDLC deliverables like validation plan, user requirement specification (URS), functional requirement specification (FRS), Design Documents.
  • Review of Test scripts (IQ, OQ and PQ documents)
  • Review of Test summary report / data migration plan / cutover plan / service transition plan.
  • Setting of effective compliance training and Internal Audit process.
  • Planning and managing of validation activities by interacting with cross-functional teams.

Testing and Validation Lead

Cognizant Technology Solutions
08.2016 - 04.2018
  • Perform integration testing of implemented configurations
  • Resolve identified issues requiring changes to implemented configurations
  • Develop UAT scripts (test cases) as per Customization and Client Requirement.
  • Responsible for creating validation master plan and test plan for LIMS & ELN
  • GAP analysis.
  • Functional Risk Assessment
  • Design of OQ and PQ scripts.
  • Preparation of RTM
  • Preparation of Validation summary report.

Application specialist / Business Analyst

Bioanalytical Technologies Pvt Ltd
02.2012 - 08.2016
  • Responsible for defining the scope of the project, gathering business requirements, GAP analysis and documentation
  • Experience in OQ and PQ of chromatography software’s.
  • Worked on site (U.K.) at the client location for software validation project.
  • SDLC documents creation for GxP computer system based on GAMP 5.
  • Managed relationship with programmers and bridged communication between end users and development team.
  • User Acceptance Testing.
  • Functional Testing.
  • Worked on implementation of 21 CFR part 11.

Research Associate (Analytical Chemist)

Piramal Life Sciences Ltd (currently known as Piramal enterprises)
03.2008 - 01.2012
  • Literature search.
  • In process, chemical reaction monitoring for API and NCE molecules.
  • Method development for Formulation (solid and liquid dosage forms), API for Non-GMP
  • And GMP lots.
  • Preparation of Method Validation Protocol for drug product & drug substances.
  • Stability studies for API and formulation products
  • Method validation of NCE’: - Assay and Related substances
  • In process sample analysis, Reaction monitoring of intermediates and testing of raw materials
  • Preparation of SOP, TTD, and reports of method development and validation of NCE’S
  • Method development and analysis of CHIRAL molecules by HPLC and GC
  • Residual Solvent analysis of finished products by GAS-chromatography.

Skills

Optimistic

Skillhighlights

IBM Rational, Doors, HPALM, 21 CFR Part 11, GxP GMP, GCP, GLP, CFR Part 280, Annex 11, Protein and Enzyme Assays, Drug Development, Analytical Instrumentation, Analytical Method development and Validation, Thermo fisher, Agilent, AB sciex, waters, Labware LIMS, Sample Manager, Perkin elimer

Academics

Jamanalal Institute of Management studies, Vellore institute of Technology, Roland Institute of Pharmaceutical Sciences

Personal Information

  • Date of Birth: 11/12/79
  • Gender: Male
  • Nationality: Indian
  • Marital Status: Married

Projects

All India Institute of Medical Sciences, 06/2006 - 07/2007, Design and synthesis of peptide inhibitors against Lipoxygenase enzyme as an anti-inflammatory agent

Disclaimer

I hereby affirm that the information provided above is true to the best of my knowledge and correct.

Timeline

Testing and Validation Lead

Cognizant Technology Solutions
08.2016 - 04.2018

Application specialist / Business Analyst

Bioanalytical Technologies Pvt Ltd
02.2012 - 08.2016

Research Associate (Analytical Chemist)

Piramal Life Sciences Ltd (currently known as Piramal enterprises)
03.2008 - 01.2012

Onsite Risk and Compliance Lead (IT compliance/Validation)

Accenture solutions PVT LTD
5 2018 - Current

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Sekhar Chandra MohantyComputer System validation specialist