Specialist, Process Optimization - Gmp Analyst

Merck & Co., Inc.

Hyderabad, India
Hybrid
Gmp sdlc deliverables ownership
Validation documentation and testing protocols
Fda ema ich regulatory framework knowledge
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.
  • The position involves owning GMP SDLC deliverables including validation documentation, testing protocols, and release planning while collaborating with cross-functional teams.
  • Candidates will contribute to SOP development and participate in workshops to define validation scope and resource needs within a global healthcare biopharma company.

Matching Summary

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

Skills & Requirements

Must-have

  • GMP SDLC deliverables ownership
  • Validation documentation and testing protocols
  • FDA EMA ICH regulatory framework knowledge
  • Jira Confluence Digital SDLC platform usage
  • Cross-functional collaboration with Quality IT

Nice-to-have

  • Manufacturing intelligence platform validation experience
  • SOP authorship and lifecycle sustainment skills
  • Automated compliance tool proficiency
  • IT Supplier Management knowledge
  • SDIRA methodology familiarity

Key Requirements

  • Bachelor's degree in Computer Science Engineering Life Sciences or related field
  • 3+ years of experience in GMP validation SDLC execution or CSV CSA methodologies
  • Strong understanding of risk-based validation approaches

Work Rights

Not specified

Tailored Resume

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