About this role
Role & Responsibilities
- Perform internal quality process assessments
- Facilitate root cause analysis on the findings from the quality process assessments
- Monitor and support operation sites on CAPA closure
- Gauge the effectiveness of the CAPA by observing the findings recurrences
- Train the operation staffs on QSA
- Conduct QSA together with the operation staff
- Identify the QSA gaps, facilitate root cause analysis and issue CAPA
- Monitor and support operation sites on CAPA closure
- Gauge the effectiveness of the CAPA by observing the PTQ score
Qualifications & Requirements
- Minimum Bachelors Degree in any relevant field added advantage for Pharmaceutical Sciences
- Minimum 5 years of experience in Quality Assurance in 3PL environments
- Professional level competencies competency in the use of Quality tools (e.g., Root Cause Analysis, CAPA, FMEA, 5 Why, Fishbone Diagram, Risk Assessment, and Audit Management
- Experience working as a Pharmacist or Life Science Regulations is an added advantage