CAPA Management Lead

We are seeking a CAPA Management Lead to oversee effective corrective and preventive action (CAPA) management for significant quality issues (QIs) and audit and inspection responses.

The successful candidate will lead and support CAPA activities, assess investigations, and ensure appropriate root cause analysis and corrective and preventative actions are implemented.

Key Responsibilities:

• Lead and mentor members of the CAPA management team
• Lead and support CAPA activities for complex QIs and sponsor audits and inspections
• Collaborate with cross-functional stakeholders to identify process gaps and areas for improvement
• Ensure proper reporting and documentation of CAPAs in the electronic quality management system (eQMS)
• Promote a culture of proactive and continuous process improvement
• Develop and provide training and guidance on Root Cause Analysis (RCA), CAPA management, and compliance adherence
• Advise Quality Assurance management on system audit needs
• Support external and internal audits and inspections

Requirements:

• 5 years of quality assurance experience within a GCP environment
• Extensive knowledge of CAPA Management, GCP guidelines, and relevant regulations
• Background in science, healthcare, or a related discipline
• Strong leadership and organisational skills
• Excellent verbal and written communication skills
• Excellent problem-solving and root cause analysis skills
• Proficient in Microsoft Office applications (Word, Excel)