CAPA Program Lead

Position : CAPA Specialist

Location : Mysore

Experience Required : 4+ years

Key Responsibilities :

• CAPA Management :
• Drive CAPA activities related to field issues, in-house issues, supplier issues, and audit findings.
• Independently produce and complete CAPA records with thorough documentation.
• Corrective & Preventive Actions :
• Develop effective corrective and preventive action plans.
• Ensure timely execution and closure of CAPA tasks.
• Root Cause Analysis & Problem Solving :
• Assess issue descriptions and review CAPA data sources.
• Assist in root cause analysis using appropriate techniques.
• Lead and mentor cross-functional teams in implementing RCA methodologies.
• Monitoring & Reporting :
• Monitor site CAPA activities and track monthly / quarterly trends.
• Evaluate the progress and effectiveness of implemented actions.
• Cross-Functional Collaboration :
• Collaborate with cross-functional teams to ensure CAPA deliverables align with project timelines.
• Schedule and manage CAPA team meetings and resource commitments.
• Audit & Review Board Representation :
• Represent CAPA activities during audits and CAPA review board meetings.
• Ensure all relevant documentation is updated and audit-ready.