QA Supervisor – Healthcare & Regulatory Compliance

DCH Auriga (Malaysia) Sdn Bhd

Shah Alam

On-site

MYR 61,000 - 106,000

Full time

4 days ago

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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.