Digital Quality, It Project Quality Manager - Mes

Lonza Group

Hyderabad, India
Not specified; not specified; comprehensive benefi...
Computer systems validation (csv) experience
Manufacturing execution systems (mes) expertise
Cgmp and regulatory compliance knowledge
This role involves leading the qualification and validation compliance of computerized systems used for cGMP activities within Lonza's Global Capability Center

Job Summary

  • This role involves leading the qualification and validation compliance of computerized systems used for cGMP activities within Lonza's Global Capability Center.
  • The position requires acting as the voice of QA in cross-functional teams to drive CSV standards and ensure data integrity across the global network.
  • Candidates will benefit from an agile career culture, global exposure, and comprehensive benefits including medical insurance and wellness programs.

Matching Summary

This role involves leading the qualification and validation compliance of computerized systems used for cGMP activities within Lonza's Global Capability Center.

Salary

Not specified; Not specified; Comprehensive benefits package including medical insurance and wellness programs

Skills & Requirements

Must-have

  • Computer Systems Validation (CSV) experience
  • Manufacturing Execution Systems (MES) expertise
  • cGMP and regulatory compliance knowledge
  • Validation strategy and execution planning
  • Test management system proficiency

Nice-to-have

  • Experience with PharmaSuite, Syncade, or MODA-ES
  • Strong organizational and problem-solving skills
  • Collaborative mindset in global teams
  • Ability to translate regulatory trends into improvements

Key Requirements

  • Degree in Life Sciences, Engineering, or Computer Science
  • Proven experience in CSV within pharmaceutical manufacturing
  • Strong understanding of GAMP 5 and FDA 21 CFR Part 11

Work Rights

Not specified

Tailored Resume

Cover Letter