Computer System Validation

1 month ago


bangalore, India 2coms Full time

Lead all aspects ofV&V for software in scope (e.g. Atlassian suite(Jira Confluence Crowd) CLM Suite(RQM )including;

Generating testprotocols plans and reports and obtainingapprovals.

Creatingand identifying tests scripts test cases and CTP/test plan/testprotocols for validation of GxPsystems.

Drafting orupdating procedural documentation in compliance with GxP proceduresand getting themapproved.

Formalexecution of scripts forValidation.

Processing Adminuser requests and User Access Management of users to GxPsystems.

GitHub (creation of repo making it GxPrelevant addingusers)

JIRAadmin requests Creation ofprojects boards integrations manage plugins creation of componentsfieldsetc

RQM/similar testmanagement tools admin requests Deletion of unwanted tests creationof application product applicability releases fields and other userissues fixes based on the issue Documentbuilder.

Document workprocesses for knowledge transfer andstorage.

Generating usercommunication regarding systems inscope.

Candidateshould be ready to WFO orHybrid.


Lead all aspects of V&V for software in scope (e.g. Atlassiansuite (Jira, Confluence, Crowd), CLM Suite (RQM) including;Generating test protocols, plans and reports and obtainingapprovals. Creating and identifying tests scripts, test cases andCTP/test plan/test protocols for validation of GxP systems.Drafting or updating procedural documentation in compliance withGxP procedures and getting them approved. Formal execution ofscripts for Validation. Processing Admin user requests and UserAccess Management of users to GxP systems. GitHub (creation ofrepo, making it GxP relevant, adding users) JIRA admin requests -Creation of projects, boards, integrations, manage plugins,creation of components fields etc RQM/similar test management toolsadmin requests - Deletion of unwanted tests, creation ofapplication product applicability, releases, fields and other userissues fixes based on the issue, Document builder. Document workprocesses for knowledge transfer and storage. Generating usercommunication regarding systems in scope. Candidate should be readyto WFO or Hybrid.

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