CAPA Coach

Role Overview

The CAPA Coach position is focused on driving corrective and preventive actions within pharmaceutical production environments. A key responsibility is to perform root cause analyses to uncover issues in manufacturing processes and to formulate corrective steps that comply with stringent FDA standards. Collaboration with various teams to enhance processes through established quality tools is essential. Additionally, the role involves educating team members to effectively apply these problem-solving methods.

Key Duties and Responsibilities

• Execute root cause analysis to identify the underlying causes of production problems.
• Design and implement corrective actions to resolve identified issues, ensuring adherence to FDA regulatory requirements.
• Work alongside cross-departmental groups to develop and apply process enhancements utilizing methods such as fishbone diagrams and the 5 Whys technique.
• Train and mentor colleagues on root cause analysis techniques to promote consistent process improvements.

Candidate Qualifications and Experience

• Possess 10 to 25 years of experience within the pharmaceutical or life sciences sectors.
• In-depth knowledge of FDA guidelines and GMP compliance standards.
• Skilled in advanced root cause analysis methods, including the application of Fishbone diagrams and 5 Whys.