Quality Assurance Manager (Lifesciences)

DHL Supply Chain; Selangor; Vor Ort; Confidential; Vollzeit

Zusammenfassung

DHL Supply Chain is seeking a QA specialist in Malaysia to perform internal quality assessments and lead root-cause analysis across sites. The role focuses on CAPA closure and monitoring CAPA effectiveness through PTQ scores, with collaboration from operation staff.

The candidate should have a minimum Bachelor’s degree, at least 5 years in Quality Assurance within 3PL environments, and strong proficiency with quality tools like RCA, CAPA, FMEA, and audit management.

Qualifikationen

• 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

Aufgaben

• 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

Kenntnisse

Quality tools usage

Regulatory knowledge

Ausbildung

Bachelor's degree in any relevant field

Tools

Root Cause Analysis

CAPA

FMEA

5 Why

Fishbone Diagram

Risk Assessment

Audit Management

Jobbeschreibung

• 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

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