Lonza
pharmaceuticaliotech
QualityEngineering,QAExpert,Commissioning&QualificationAuditandInspectionSupport
Neural analysis suggests this role is
optimal for Mid candidates.
“Quality Engineering, QA Expert, Commissioning & Qualification Audit and Inspection Support at Lonza. Skills: Quality Engineering, Commissioning & Qualification, Audit and Inspection Support. Ensure compliance with cGMP. Provide quality oversight”
What You'll Achieve.
Deliver our best work; Strengthen inspection readiness; Ensure quality consistency; Deliver on KPIs; Ensure excellence in execution
Industry & Context.
Problem-solving skills; Analytical skills
What They're Looking For.
Must Have
Minimum 5 years in regulated pharmaceuticaliotech industry (engineering, QA, QC, manufacturing, R&D, or regulatory affairs), Experience in chemicaliological GMP API manufacturing, Interpretation of EMA/FDA/ICH/PIC/S requirements, Proven management experience in regulated environments, Knowledge of CQV approaches, Knowledge of facility design quality systems, Knowledge of internal audit planning
What You'll Do.
Ensure compliance with cGMP
Provide quality oversight
Drive standardization of engineering standards
Support audits and inspections
Ensure commissioning and qualification activities meet expectations
Provide technical expertise
Translate regulatory trends into improvements
Lead remediation plans
Coordinate cross-functional remediation efforts
Monitor corrective action effectiveness
Conduct evaluations across projects/sites
Align CAPEX execution with expectations
Supervise and maintain oversight of CAPA lifecycle
Review and approve technical documentation
Uphold data integrity principles
Drive continuous improvement
Support audits and inspections
How You'll Work.
Team & Collaboration
Collaboration; Stakeholder management; Work effectively across teams
Communication Scope
Communication; Influencing skills
Process & Methodology
Project management proficiency, Risk-based approach
Full Job Description
# 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 (B
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