QA Expert – Commissioning & Qualification, Audit & Inspection Support

Organization: Global Quality Engineering Location: Hyderabad, India 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 Sciences.

Experience

• Minimum 5 years in regulated pharmaceutical/biotech industry (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.

• Proven management experience in regulated environments.

• Knowledge of CQV approaches, facility design quality systems, and internal audit planning.

Skills

• Strong communication and influencing skills across organizational levels.

• Effective collaboration and stakeholder management.

• Ability to lead, mentor, and coach teams.

• Strong organizational, analytical, and problem‑solving skills.

• Expertise in engineering and cGMP manufacturing of APIs.

• Project management proficiency with a risk‑based approach to quality systems.

Core Competencies

• Agility: Learns from setbacks, embraces change, drives improvements.

• Business Acumen: Aligns decisions with corporate strategy, identifies operational improvements.

• Collaboration: Works effectively across teams, champions diversity and inclusion.

• Customer Focus: Anticipates customer needs, manages relationships professionally, drives satisfaction.

• Driving Results: Delivers on KPIs, prioritizes effectively, ensures excellence in execution.

• Leadership: Creates a positive work environment, fosters accountability, supports professional development.