). This role combines strategic ownership of quality systems (e.g., eQMS, CAPA, change control, document control) with hands... as relevant). Lead the administration and optimization of digital QMS tools: document management, CAPA, nonconformance, change...
to training and development, participate in audits, and support CAPA initiatives to enhance product quality and regulatory...
-of-specification (OOS) results Support Root Cause Analysis and follow-up of Corrective and Preventive Actions (CAPA) Ensure the...
) audits. Lead product-related Corrective and Preventive Action (CAPA) discussion and closure. - Ensure continuous quality...
and implementation of preventive and corrective actions that may result from production non-conformances, audit observations, CAPA...
of corrective and preventive actions (CAPA). - Support containment activities for quality escapes and non-conformances. - Drive... Skills- Working knowledge of:- SPC- FMEA- MSA- DOE- Control Plans- Root Cause Analysis- CAPA- Statistical analysis tools...
and validate corrective and preventive actions (CAPA). Design Changes & Engineering Change Management Create, review, and approve...
with CAPA investigations, effectiveness checks, and remediation actions.Develop, review, implement, and improve Quality..., Design Assurance, Risk Management, CAPA, Verification & Validation, Process Validation (IQ/OQ/PQ), Technical Documentation...
validation and verification according to quality system procedures. May lead or participate in CAPA activities...
controls, deviations, CAPA, authority inspections, self-inspections, GxP surveillance, product quality reviews, training, local... management for internal, external, and transport deviations. - CAPA management from deviations, internal audits, external audits...