Quality Engineering, QA Expert, Commissioning & Qualification Audit and Inspection Support
Core
Ensures compliance with cGMP and international regulatory requirements by providing quality oversight for global growth projects and CAPEX investments, acting as the Global QA representative.
Role type
Senior Quality Engineering Expert (Commissioning, Qualification, Audit & Inspection)
Builds
Global growth projects and CAPEX investments
Domain
Regulated pharmaceutical/biotech industry (API manufacturing)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, regulatory interpretation (EMA/FDA/ICH/PIC/S), CQV approaches, facility design quality systems, internal audit planning, CAPA lifecycle management, risk-based quality systems, engineering expertise in API manufacturing
Preferred skills
Project management, stakeholder management, team leadership and mentoring
Technologies
None explicitly stated
Responsibilities
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; Review and approve technical documentation, risk assessments, and regulatory responses; Support audits, inspections, and process qualification activities for growth projects
Seniority
Senior, hands-on IC with management experience
