Quality Assurance Manager (Lifesciences)

Deutsche Post; Selangor; On-site; MYR 134,000 - 201,000; Full time

Job summary

Deutsche Post Malaysia seeks a Quality Assurance professional to perform internal quality process assessments across 3PL operations and to facilitate root cause analysis on findings. You will support CAPA closure at operation sites and monitor CAPA effectiveness through observed recurrences.

The role also involves training operation staff on QSA and conducting QSA with the team to identify gaps and ensure compliance with quality standards.

Qualifications

• Bachelor's degree in any relevant field; pharmaceutical sciences is an added advantage.
• Minimum 5 years of quality assurance experience in 3PL environments.
• Proficient in quality tools including RCA, CAPA, FMEA, 5 Why, Fishbone diagrams, risk assessment and audit management.
• Experience as a Pharmacist or familiarity with Life Science regulations is advantageous.

Responsibilities

• Perform internal quality process assessments.
• Facilitate root cause analysis on findings from the assessments.
• Monitor and support operation sites on CAPA closure.
• Gauge CAPA effectiveness by observing recurrence of findings through PTQ scores.

Skills

Quality tools

Education

Bachelor’s degree (any relevant field)

Tools

Root Cause Analysis (RCA)

CAPA

FMEA

5 Why

Fishbone Diagram

Risk Assessment

Audit Management

Job description

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