audits, and coordinates resolution of site audit findings on a country/regional level. Oversees project team in CAPA...
audits, and coordinates resolution of site audit findings on a country/regional level. Oversees project team in CAPA...
cause analysis and corrective action systems (8D, 5 Why, Ishikawa, CAPA). Ability to analyze manufacturing data and drive...
, and contributes to CAPA implementation and project compliance activities. Maintains TMF/eTMF quality and inspection readiness...
actions (CAPA) for process deviations or inefficiencies. Support the introduction of new products (NPI) by defining process...
Job Description Audit Schedule Completion =100% On-Time Completion of Validation Testing: ≥ 95% CAPA... control, including procedures, work instructions, and quality records. Lead corrective and preventive actions (CAPA) using...
-cause analysis, CAPA processes, and documentation practices Strong knowledge of regulatory and industry frameworks (GLP...
failure mode, root cause, and corrective actions. Support continuous improvement and corrective action processes (CAPA...
investigations and CAPA resolution for critical issues. Oversee process improvement initiatives for quality systems. Author, review..., and regulatory compliance. Advanced project management and technical analysis skills. Leadership in root cause analysis and CAPA...
, and collaboration tools to maintain stakeholder alignment. Maintain audit-ready records, CAPA documentation, 8D reports, and customer... of Salesforce, SAP/QEHS claims systems, customer portals, CAPA/8D documentation, and complaint handling processes. Strong...