Quality Engineering, QA Expert, Commissioning & Qualification Audit and Inspection Support

Overview

QA Expert for Commissioning & Qualification with responsibility for quality oversight, documentation support, and audit/inspection readiness across global projects in regulated environments.

What you'll do

• 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.
• Support evaluations across projects/sites to align CAPEX execution with Health Authority expectations.
• Supervise and maintain oversight of the CAPA lifecycle with risk-based, compliant implementation.
• Review and approve technical documentation, risk assessments, and regulatory responses.
• Support audits, inspections, and process qualification activities for growth projects.

What you'll need

• 5+ years in regulated pharmaceutical/biotech industry across roles such as engineering, QA, QC, manufacturing, R&D, or regulatory affairs.
• Experience in chemical/biological GMP API manufacturing and interpretation of EMA/FDA/ICH/PIC/S requirements.
• Engineering or Biological Sciences degree (Bachelor’s or Master’s) in Biologics/Chemical or Biological Sciences.
• Knowledge of CQV approaches, facility design quality systems, and internal audit planning.
• Proven management experience in regulated environments.
• Project management proficiency with a risk-based approach to quality systems.
• Strong communication, influencing, and stakeholder management skills.

Details

• Office-first in Hyderabad, India; remote flexibility for 20% of time (one day per week).