Quality Assurance Officer

Intrinseque Health Pte Ltd.; Malacca City; Sur place; MYR 35 000 - 55 000; Plein temps

Résumé du poste

Intrinseque Health Pte Ltd. in Melaka is seeking a full-time on-site Quality Assurance Officer to oversee the implementation and maintenance of quality systems in line with ISO and GDPMDS standards for the clinical supply chain.

You will review and update quality documentation and SOPs, monitor regulatory and internal compliance, and coordinate CAPAs to address non-conformities. The role also involves internal quality checks, supporting audits, analyzing data trends, and collaborating with

Qualifications

• Candidates should possess skills in Quality Assurance and Quality Management to develop, implement, and maintain robust quality systems.
• Strong Analytical Skills to interpret quality data, identify trends, assess risks, and recommend practical improvements.
• Experience working within ISO-certified environments (e.g., ISO 13485, ISO 9001, ISO 27001) or regulated healthcare, pharmaceutical, or medical device settings is beneficial.
• Strong attention to detail, structured documentation skills, and the ability to follow and refine SOPs are required.
• Effective communication and collaboration skills, with the ability to work cross-functionally with operations, logistics, and project teams.

Responsabilités

• Review and update quality documentation and SOPs.
• Monitor compliance with internal procedures and regulatory requirements.
• Coordinate CAPA to address non-conformities.
• Conduct internal quality checks and support audits/inspections.
• Analyze quality data and trends to drive improvements.
• Collaborate with operations, logistics, and project management teams.
• Assist in training team members on quality policies.
• Contribute to risk assessments and process optimization initiatives.

Connaissances

Quality Assurance

Quality Management

Analytical Skills

Description du poste

Role Description

This is a full-time, on-site Quality Assurance Officer role based in Melaka. The Quality Assurance Officer will oversee implementation and maintenance of quality systems aligned with ISO and GDPMDS standards, supporting clinical supply chain operations. Daily responsibilities include reviewing and updating quality documentation and SOPs, monitoring compliance with internal procedures and regulatory requirements, and coordinating corrective and preventive actions (CAPA) to address non-conformities. The role involves conducting internal quality checks, supporting audits and inspections, analyzing quality-related data and trends, and collaborating with operations, logistics, and project management teams to ensure continuous improvement. The Quality Assurance Officer will also assist in training team members on quality policies and contribute to risk assessments and process optimization initiatives.

Qualifications

• Candidates should possess skills in Quality Assurance and Quality Management to develop, implement, and maintain robust quality systems and procedures.


• Candidates should possess strong Analytical Skills to interpret quality data, identify trends, assess risks, and recommend practical improvements.


• Experience working within ISO-certified environments (e.g., ISO 13485, ISO 9001, ISO 27001) or regulated healthcare, pharmaceutical, or medical device settings is beneficial.


• Strong attention to detail, structured documentation skills, and the ability to follow and refine SOPs are required.


• Effective communication and collaboration skills, with the ability to work cross-functionally with operations, logistics, and project teams.