Senior Specialist, Dracoe Process Sme

Memorialdrivevetclinic

Hyderabad, India
Hybrid
Gxp and non-gxp application lifecycle management
System decommissioning and archival processes
Regulatory compliance (gxp, 21 cfr part 11)
Define, maintain, and continuously enhance standard operating procedures (SOPs), work instructions, templates, and process frameworks for system decommissioning, retirement and archival

Job Summary

  • Define, maintain, and continuously enhance standard operating procedures (SOPs), work instructions, templates, and process frameworks for system decommissioning, retirement and archival.
  • Ensure decommissioning and archival activities comply with applicable regulations and standards (e.g., GxP, 21 CFR Part 11, EU Annex 11, data integrity principles, records retention and privacy requirements).
  • Promote awareness of DRACoE processes and standards through communication, training, and stakeholder engagement across divisions and regions.

Matching Summary

Define, maintain, and continuously enhance standard operating procedures (SOPs), work instructions, templates, and process frameworks for system decommissioning, retirement and archival.

Skills & Requirements

Must-have

  • GxP and non-GxP application lifecycle management
  • System decommissioning and archival processes
  • Regulatory compliance (GxP, 21 CFR Part 11)
  • Data integrity principles
  • ServiceNow and Jira configuration
  • Stakeholder management and collaboration

Nice-to-have

  • Digital technology and data-backed approaches
  • Innovation and execution excellence
  • Global collaboration and best practices
  • Scalable operating model development

Key Requirements

  • 7-10 years of experience in shared services or global process owner role
  • Bachelor’s degree in information technology, Computer Science, Information Systems or related field
  • Familiarity with data retention regulations and archival technologies
  • Proven experience designing or operating system lifecycle management processes
  • Hands-on experience with ServiceNow and Jira configuration in a regulated environment

Work Rights

Not specified

Tailored Resume

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