Lead and support CAPA investigations end-to-end, including issue identification, root cause analysis, corrective actions, effectiveness checks, and closure in line with regulatory and QMS requirements
Job Summary
Lead and support CAPA investigations end-to-end, including issue identification, root cause analysis, corrective actions, effectiveness checks, and closure in line with regulatory and QMS requirements.
Partner cross-functionally with Quality, Engineering, Manufacturing, Service and Commercial teams to ensure timely execution of CAPA actions, adequate resourcing, and sustained compliance.
Strengthening the compliance culture by training and mentoring teams on QMS, CAPA, regulatory expectations, and best practices across the organization.
Matching Summary
Lead and support CAPA investigations end-to-end, including issue identification, root cause analysis, corrective actions, effectiveness checks, and closure in line with regulatory and QMS requirements.
Skills & Requirements
Must-have
CAPA investigations end-to-end
root cause analysis
quality data analysis
QMS and regulatory expectations
FDA regulated manufacturing/quality
Nice-to-have
cross-functional partnership
strengthening compliance culture
proactive compliance interventions
continuous improvement
Key Requirements
Minimum 5+ years experience
Bachelor's Degree in Engineering, Sciences, or equivalent