Thana Subramanian work email
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Specialties: Computerised Systems Validation, Project Quality Assurance, Computerised Systems Supplier Auditor, Internal Computerised Systems Validation Auditor. Global IT systems, (SAP, Oracle, Safety databases, Documentum, etc), Process Control systems (DCS, SCADA, PLC) Lab Systems (LIMS, CDS, Instrument control) to End user applications (Access, Excel Spreadsheets)
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IspeUnited Kingdom -
Gamp Global Steering Committee SecretaryIspe Oct 2023 - PresentNorth Bethesda, Maryland, Us
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Gamp Europe Cop Steering Committee ChairIspe Oct 2019 - Oct 2023North Bethesda, Maryland, Us
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Gamp Uk Cop Steering Committee ChairIspe Dec 2010 - Oct 2019North Bethesda, Maryland, UsApril 2012 - Presented Promotional PracticesOct 2012 - Co-Facilitated Risk Management WorkshopApril 2014 - Presented Data Integrity in Lab - Spreadsheets. Co-facilitated Cloud Round Table
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Head Of QualityIntegrity Sep 2021 - PresentOxford, Kidlington, Gb -
It Committee MemberResearch Quality Association (Rqa) Oct 2021 - PresentIpswich, Suffolk, Gb -
Director, Global Quality Systems, Csv Audit Lead. Deputy Head Of Global Quality - Region EuropeOtsuka Pharmaceutical Companies Europe Dec 2016 - Sep 2021Windsor, Berkshire , GbManaging a team of CSV auditors, planning, performing, reporting and approving CAPAs for systems audits across the GxP domain. Global Qualiy lead for Data Integrity programme. -
Associate Director, Clinical Quality ManagementOtsuka Pharmaceutical Companies Europe May 2016 - Dec 2016Windsor, Berkshire , Gb
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Senior Specialist Clinical Quality ManagementOtsuka Pharmaceutical Companies Europe Sep 2014 - May 2016Windsor, Berkshire , GbPharmacovigilance Computerised Systems Validation Quality Auditor
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Digit Committee MemberRqa Jan 2006 - Dec 2019Ipswich, Suffolk, GbContributed to Auditing Computerised System BookletI have presented:“eCRF deployment conisderations & identification of audit targets for EDC studies” BARQA annual conference 2012“The project team handed you the ‘torch’ - As a System Owner what do you do now?” BARQA annual conference 2012“An Auditor’s Guide to the auditing of e-CRFs, data integrity and related compliance issues” RQA in run annually from 2008 to 2013“Auditing Computerised Systems” BARQA in June 2010, 2012, 2014, 2015, 2016, 2017 & 2018 (now as Course Principle)“E-Source Friend or Foe” BARQA & ICR joint Seminar in June 2008
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Head Of Computerised Systems Validation StrategyRoche Jul 2013 - Aug 2014Switzerland 🇨🇭 , ChResponsible for the development and implementation of the Product Development QA CSV risk-based strategy for audit and non-audit activities globally, covering all regulated systems used by Pharma global functions, affiliates and service providers. -
Director Qa Software And InstrumentationGe Healthcare Jan 2006 - Jun 2013Chicago, UsResponsible for QA Computerised Systems Validation & Compliance for GEHC's Pharma arm, Medical Diagnostics covering all GxP's.System owner reponsibility for eDMS, Change Control, CAPA, Compliants eTools.Manage a global team of experts across 10 sites. -
Programme ManagerGlaxosmithkline Jan 2002 - Dec 2005Brentford, Middlesex, GbR&D Computer Systems Compliance and Clinical Compliance Auditor and Project SupportResource ManagerMatrix Manager -
Computer System Validation ManagerGlaxosmithkline Aug 1999 - Jan 2002Brentford, Middlesex, GbResponsible for team of Computer Validation Engineers. Ensuring computer systems compliance (validation and Part 11) for Secondary Manufacturing Site and key contract manufacturersCompleted major revalidation project for all site systems & supported prospective projects LIMS, DCS, PLC, Lab systems & end user developed spreadsheet & database applications.Performed internal audits across UK sites and provided CSV training to site.Key involvement in setting group standards on 21CRFPart11 & end user developed applications
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Senior Systems EngineerMerck Sharp & Dohme Mar 1997 - Aug 1999Rahway, New Jersey, UsAs Computer Validation Co-ordinator I was responsible for the Site Computer Validation Strategy Plan and CSV projects across the site including MRPII, CMMS, DCS, PLC & Lab systems.As Year 2000 Site Co-ordinator, responsible for the six phases, Awareness, Inventory, Assessment and Planning, Remediation, Testing and Field. -
Validation EngineerRaytheon Engineers & Constructors May 1996 - Mar 1997Validation consultant for following clientsPfizer, KentGist-Brocades, MexicoShionogi, Japan.Eisai Co. Ltd. Kawashima, JapanJanssen Pharmaceutica, Belgium.Gedeon Richter, Hungary.Rhone-Poulenc, Ireland.
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Technical Support TechnologistHoffmann-La Roche Oct 1993 - May 1996Switzerland 🇨🇭 , ChTechnical Support Group – All aspects of Sterile equipment and secondary equipment validation, including CSV
Thana Subramanian Skills
Thana Subramanian Education Details
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Kingston UniversityAdvanced Manufacturing Systems -
University Of BradfordChemical Engineering
Frequently Asked Questions about Thana Subramanian
What company does Thana Subramanian work for?
Thana Subramanian works for Ispe
What is Thana Subramanian's role at the current company?
Thana Subramanian's current role is Head Of Quality at Integrity.
What is Thana Subramanian's email address?
Thana Subramanian's email address is thanabalan.subramanian@ge.com
What is Thana Subramanian's direct phone number?
Thana Subramanian's direct phone number is +4414945*****
What schools did Thana Subramanian attend?
Thana Subramanian attended Kingston University, University Of Bradford.
What skills is Thana Subramanian known for?
Thana Subramanian has skills like Computer System Validation, Validation, Gxp, Change Control, Quality Assurance, Gamp, Pharmaceutical Industry, 21 Cfr Part 11, Capa, Gmp, Fda, Quality System.
Who are Thana Subramanian's colleagues?
Thana Subramanian's colleagues are Ana Marie Kaneto, Rodrigo Cardoso, Jülide Metinkaya, Mark Stefko, Ray Bar, Rosemary Jones, Elfescu Lara.
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