CAPA Coach

Roles and Responsibilities :

• Conduct root cause analysis (RCA) to identify the source of problems in production processes.
• Develop and implement corrective actions to address identified issues, ensuring compliance with FDA regulations.
• Collaborate with cross-functional teams to design and execute process improvements, leveraging tools such as fishbone diagrams and 5 Whys.
• Provide training and coaching to team members on RCA methodologies, ensuring effective implementation of new procedures.

Job Requirements :

• 10-25 years of experience in pharmaceutical or life sciences industry.
• Strong understanding of FDA regulations and guidelines for GMP compliance.
• Proficiency in conducting Root Cause Analysis (RCA), including Fishbone diagramming and 5 Why techniques.