Senior Specialist, Dracoe Process Sme

medhunter.de

Hyderabad, India
Hybrid
Gxp and non-gxp application lifecycle management
System decommissioning and archival processes
Regulatory compliance (gxp, 21 cfr part 11, eu annex 11)
Join a global healthcare biopharma company with a 130-year legacy, driven by digital technology and data-backed approaches to tackle global health threats

Job Summary

  • Join a global healthcare biopharma company with a 130-year legacy, driven by digital technology and data-backed approaches to tackle global health threats.
  • Define, govern, and continuously improve end-to-end processes for decommissioning, retirement, and archival of GxP and non-GxP applications, data, and related assets.
  • Collaborate with business owners, IT, Quality, Records Management, Data Privacy, and Information Security to design compliant and fit-for-purpose strategies.

Matching Summary

Join a global healthcare biopharma company with a 130-year legacy, driven by digital technology and data-backed approaches to tackle global health threats.

Skills & Requirements

Must-have

  • GxP and non-GxP application lifecycle management
  • System decommissioning and archival processes
  • Regulatory compliance (GxP, 21 CFR Part 11, EU Annex 11)
  • Data integrity and retention 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
  • Passion for data and analytics

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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