Lonza

pharmaceuticaliotech

QualityEngineering,QAExpert,Commissioning&QualificationAuditandInspectionSupport

Hyderabad, India FULL TIME Remote Friendly
The Brief

“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.

pharmaceuticaliotech
Problems you'll solve

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

Free ATS check

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