QA Expert – Commissioning & Qualification, Audit & Inspection Support

Organization: Global Quality Engineering
Location: Hyderabad, India

This is an office‑first role. Working together in person supports close, real‑time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (one day per week).

Reports to: Global Quality Engineering Leadership

Job Description Summary
The QA Expert ensures compliance with cGMP and international regulatory requirements by providing quality oversight for global growth projects and CAPEX investments. Acting as Global QA’s representative, the role drives standardization of engineering standards, supports audits and inspections, and ensures commissioning and qualification activities meet Lonza and regulatory expectations. The position provides technical expertise, risk management, and documentation support to strengthen inspection readiness and quality consistency across projects.

Key Accountabilities




- Translate regulatory trends and inspection outcomes into actionable quality improvements.
- Lead remediation plans from Project Quality Reviews and regulatory audit observations.
- Coordinate cross‑functional remediation efforts and monitor corrective action effectiveness.
- Conduct evaluations across projects/sites to align CAPEX execution with Health Authority expectations.
- Supervise and maintain oversight of CAPA lifecycle, ensuring risk‑based and compliant implementation.
- Review and approve technical documentation, risk assessments, and regulatory responses.
- Uphold Lonza’s data integrity principles and drive continuous improvement.
- Support audits, inspections, and process qualification activities for growth projects.
- Perform other duties as required to support Global Quality Engineering objectives.

Qualifications
Education
- Bachelor’s or Master’s degree in Engineering (Biologics/Chemical) or Biological Sci

📌 Quality Engineering, QA Expert, Commissioning (Hyderabad)
🏢 Lonza
📍 Hyderabad