Job Description Summary

The Technology and Global Services (TGS) Validation & Compliance Archivist role is primarily responsible for the management of software development lifecycle (SDLC) documents used for Computer System Validation (CSV) and compliance evidence. The Archivist will work with the Validation Center of Excellence (COE) and cross-functional stakeholders to ensure configuration data in the repository, metadata related to the documents and assessment information is accurate. This individual will work with the TGS IT Process and Compliance team to proactively provide complete, accurate and accessible validation and compliance documentation to help meet the team’s audit readiness process. This individual will work to build a mapping index between project and functional documentation for the systems lifecycle.

Job Description

Corrective and Preventive Actions (CAPA) and Audit Response Readiness

• Collaborates with IT Process and Compliance team to ensure operational readiness for audit requests and responsiveness.
• Work as part of the validation COE and other cross-functional teams to ensure validation and compliance evidence is effectively managed, tagged and stored in the appropriate repository.

IT CSV

• Performing validation activities to implement and maintain IT systems.
• Provides direction related to validation topics to project teams.
• Authors and approves appropriate SDLC documentation to assess project teams in the development of software in a compliant manner.
  

Records Retention / Document Control

• Work with the cross-functional teams to ensure applicable documentation gaps are remediated and processes are in place to maintain the integrity of the validation and compliance documentation.  This includes validation and compliance plans, test evidence, validation and compliance summary reports, decommission plans and all other identified validation and compliance deliverables.  
• Work with document control team to ensure data integrity of the document taxonomy (e.g. naming convention, document linkages including parent to child)

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift