Quality Operations Specialist – external Manufacturing

Lonza Group

Hyderabad, India
Review gmp batch documentation from cdmo partners
Ensure data integrity and regulatory compliance
Evaluate analytical data and certificates of analysis
The role involves performing detailed reviews of GMP batch documentation from CDMO partners to ensure compliance with Lonza quality standards

Job Summary

  • The role involves performing detailed reviews of GMP batch documentation from CDMO partners to ensure compliance with Lonza quality standards.
  • Candidates will support quality oversight of external manufacturing activities, including preparing for batch disposition and identifying compliance risks.
  • Lonza offers an agile career with opportunities to collaborate with global cross-functional teams and ongoing professional development.

Matching Summary

The role involves performing detailed reviews of GMP batch documentation from CDMO partners to ensure compliance with Lonza quality standards.

Skills & Requirements

Must-have

  • Review GMP batch documentation from CDMO partners
  • Ensure data integrity and regulatory compliance
  • Evaluate analytical data and Certificates of Analysis

Nice-to-have

  • Experience in CDMO environments
  • Strong attention to detail for complex docs
  • Ability to work cross-functionally with global teams

Key Requirements

  • Bachelor's degree in Chemistry, Biotechnology, or Pharmaceutical Sciences
  • Understanding of GMP documentation and data integrity requirements
  • Business fluency in English

Work Rights

Not specified

Tailored Resume

Cover Letter