) compliance of documental system, non-conformities, Corrective Action Preventive Action (CAPA), Complaints, Self-Inspections...
to identify systemic issues. Support Corrective and Preventive Actions (CAPA) to improve product reliability. Act as a liaison...
activities, complaint trending, data analysis, CAPA-related activities when assigned, audits/inspections, and cross-functional...
9001 requirements Internal auditing and compliance management Corrective and Preventive Action (CAPA) management Root...
Orchestrate Medical Affairs functional capabilities evolution at Cluster level Audit Readiness and CAPA response follow up...
on production line transfers or improvements as required. Support corporate Quality improvement CAPA implementations and lead QA...
expertise in Change Management, Change Control, CAPA execution, and manufacturing process within regulated manufacturing... and drive corrective actions when implementation objectives are not achieved. Support CAPA activities related to process...
Orchestrate Medical Affairs functional capabilities evolution at Cluster level Audit Readiness and CAPA response follow up...
/studies. Prepare and follow up on site and country audits, CAPA preparation and implementation. Accountable for resource...
13485:2016, FDA (21 CFR Part 820) and NOM-241-SSA1-2021 requirements). CAPA/Deviation administration. Monitoring trends...