Sabarinath Email & Phone Number | 5 years of Retail and Logistics QA experience. 12 years of Computer System Validation, Compliance Management, Test Management and Domain Consultancy experience in Life Sciences domain. Having first class leadership, management and communication skills and capable of providing authoritative guidance and advice to teams. Life Sciences Domain experience – Regulatory Affairs, Clinical, Manufacturing, Sales & Marketing. Experience in FDA regulated Pharmaceutical industries with emphasis on Computer System Validation (CSV). Extensive understanding of Good Practice quality regulations (GxPs) and FDA 21 CFR Part 11 (Electronic Records and Electronic Signatures). 6 years of experience working at the client location (USA) for Abbott Laboratories. 4+ years of experience working as a Validation/Compliance Lead at client location (Abbott Laboratories) with experience in facing audits and participating in process and compliance discussions. COTS experience: LS Regulatory Affairs –  FirstDoc Document Management (CSC)  xmLabeling (Glemser)  eCTDXPress (CSC) LS Clinical –  IMPACT (Parexel) LS Manufacturing –  POMSnet MES (POMS) General –  Documentum (EMC)  SharePoint (Microsoft)  GQMS Experience in various phases of Software Lifecycle including system analysis, requirement gathering, functional requirement analysis, planning and strategizing, end-to-end validation. Performing Quality reviews on SDLC artifacts; Manage Quality Governance Board for Quality Checkpoints. Proficient in writing and reviewing Validation Change Requests, Validation Plans, Validation Protocols, Validation Summary Reports, Incident Reports, Validation Requirements. Customizing/optimizing process for System Development, Maintenance, Retirement Lifecycles.

Sabarinath

5 years of Retail and Logistics QA experience. 12 years of Computer System Validation, Compliance Ma...
India

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Sabarinath ’s Email sabarinath@infosys.com

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Work Experience

Infosys

Project Manager - Ivs

Present

Cognizant

Test Manager

2003-10-01 00:00:00 - 2015-10-01 00:00:00

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Sabarinath is a 5 years of Retail and Logistics QA experience. 12 years of Computer System Validation, Compliance Management, Test Management and Domain Consultancy experience in Life Sciences domain. Having first class leadership, management and communication skills and capable of providing authoritative guidance and advice to teams. Life Sciences Domain experience – Regulatory Affairs, Clinical, Manufacturing, Sales & Marketing. Experience in FDA regulated Pharmaceutical industries with emphasis on Computer System Validation (CSV). Extensive understanding of Good Practice quality regulations (GxPs) and FDA 21 CFR Part 11 (Electronic Records and Electronic Signatures). 6 years of experience working at the client location (USA) for Abbott Laboratories. 4+ years of experience working as a Validation/Compliance Lead at client location (Abbott Laboratories) with experience in facing audits and participating in process and compliance discussions. COTS experience: LS Regulatory Affairs –  FirstDoc Document Management (CSC)  xmLabeling (Glemser)  eCTDXPress (CSC) LS Clinical –  IMPACT (Parexel) LS Manufacturing –  POMSnet MES (POMS) General –  Documentum (EMC)  SharePoint (Microsoft)  GQMS Experience in various phases of Software Lifecycle including system analysis, requirement gathering, functional requirement analysis, planning and strategizing, end-to-end validation. Performing Quality reviews on SDLC artifacts; Manage Quality Governance Board for Quality Checkpoints. Proficient in writing and reviewing Validation Change Requests, Validation Plans, Validation Protocols, Validation Summary Reports, Incident Reports, Validation Requirements. Customizing/optimizing process for System Development, Maintenance, Retirement Lifecycles.