Specialist, Process Optimization - Gmp Analyst

539

Hyderabad, India
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

Job Summary

  • This role is critical to ensuring regulatory alignment and operational continuity across quarterly release cycles.
  • The successful candidate will own and execute GMP SDLC deliverables including validation documentation and testing protocols.
  • Join a global healthcare biopharma company with a 130-year legacy of success backed by ethical integrity.

Matching Summary

This role is critical to ensuring regulatory alignment and operational continuity across quarterly release cycles.

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 platforms
  • SOP authorship skills
  • Automated compliance tools
  • IT Supplier Management knowledge
  • Digital transformation initiatives

Key Requirements

  • Bachelor's degree in Computer Science, Engineering, or Life Sciences
  • 3+ years of experience in GMP validation or CSV/CSA methodologies
  • Strong understanding of FDA and EMA regulatory frameworks

Work Rights

Not specified

Tailored Resume

Cover Letter