Quality Assurance Supervisor

DCH Auriga (Malaysia) Sdn Bhd; Shah Alam; On-site; MYR 61,000 - 106,000; Full time

Job summary

DCH Auriga Malaysia Sdn Bhd is seeking an experienced Supervisor - Quality Assurance to strengthen our QA function within healthcare distribution operations. The role focuses on maintaining the Quality Management System, ensuring regulatory compliance, supporting audits, and driving continuous quality improvement across pharmaceutical and medical device activities.

You will lead QMS activities, manage CAPA and investigations, ensure release readiness, collaborate with operations, regulatory

Qualifications

• Bachelor’s or Diploma in Life Sciences or related field with relevant QA experience.
• Experience in quality audits, CAPA, investigations, validation and QMS is advantageous.
• Strong knowledge of GDPMD, GMP, GSDP and ISO 9001 is required.

Responsibilities

• Maintain QMS in line with GDPMD, GMP, GSDP and ISO 9001 standards.
• Lead internal and external audits including principal and customer audits.
• Manage quality documentation, complaints, investigations, CAPA and follow-up actions.
• Ensure products meet regulatory requirements prior to release.
• Collaborate with Operations, Regulatory Affairs, commercial teams, principals and customers on quality matters.
• Drive continuous improvement and strengthen quality awareness across the organization.

Skills

Quality Assurance

Audits

CAPA

Regulatory compliance

Education

Life Sciences degree

Diploma with experience

Job description

We’re Hiring : Supervisor - Quality Assurance (QA)

DCH Auriga Malaysia is looking for an experienced Supervisor - Quality Assurance to strengthen our Quality function within our healthcare distribution operations.

This role will play an important part in maintaining our Quality Management System, ensuring regulatory compliance, supporting internal and external audits, and driving continuous quality improvement across pharmaceutical and medical device operations.

Key Responsibilities

• Maintain Quality Management System requirements in accordance with GDPMD, GMP, GSDP and ISO 9001 requirements.
• Ensure compliance with regulatory and Ministry of Health requirements within the contracted service scope.
• Lead and support internal and external quality audits, including principal and customer audits.
• Manage quality procedures, documentation, complaints, investigations, CAPA and follow-up actions.
• Conduct root cause investigations and develop effective corrective and preventive actions.
• Support validation, revalidation, requalification and quality improvement activities.
• Ensure pharmaceutical and medical device products meet applicable quality and regulatory requirements prior to release.
• Work closely with Operations, Regulatory Affairs, commercial teams, principals and customers on quality-related matters.
• Liaise with regulatory bodies and external parties on quality system requirements.
• Drive continuous improvement and strengthen quality awareness across the organization.

Requirements

• Degree in Life Sciences or a related discipline. Candidates with a Diploma and relevant experience may also be considered.
• Relevant experience in Quality Assurance within pharmaceutical, medical device, healthcare distribution or a related regulated environment.
• Good knowledge of GDPMD, GMP, GSDP and ISO 9001 requirements.
• Experience in quality audits, CAPA, investigations, validation and Quality Management Systems will be an advantage.
• Strong communication and stakeholder management skills.
• Able to work independently in a fast-paced environment.