Specialist, Process Optimization - Gmp Analyst

med-in.at

Hyderabad, India
Not specified; not specified; not specified
Hybrid
Gmp validation experience
Sdlc execution expertise
Jira and confluence proficiency
This role is critical to ensuring regulatory alignment and operational continuity across quarterly release cycles and long-term system lifecycle management

Job Summary

  • This role is critical to ensuring regulatory alignment and operational continuity across quarterly release cycles and long-term system lifecycle management.
  • You will collaborate with cross-functional teams including Quality, IT, and Product to ensure compliance with SDLC-SOP-09 and CSA methodology.
  • The position offers a strategic opportunity to drive compliance, innovation, and operational excellence within a high-performing global technology team.

Matching Summary

This role is critical to ensuring regulatory alignment and operational continuity across quarterly release cycles and long-term system lifecycle management.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • GMP validation experience
  • SDLC execution expertise
  • Jira and Confluence proficiency
  • FDA and EMA regulatory knowledge
  • Risk-based validation approaches

Nice-to-have

  • Manufacturing intelligence platform support
  • SOP authorship and lifecycle sustainment
  • Automated compliance tools knowledge
  • Cross-functional stakeholder engagement

Key Requirements

  • Bachelor's degree in Computer Science or related field
  • 3+ years of GMP validation or CSV/CSA experience
  • Regular employee status required

Work Rights

Not specified

Tailored Resume

Cover Letter