*URGENT* Entry Level QA Compliance Associate (Contract, Tuas, Medical Pharma MNC, up to $4200) - HWX

• Support the implementation and maintenance of the Quality Management System (QMS)
• Ensuring alignment with company standards and policies, as well as applicable customer and regulatory requirements.
• Responsible for ensuring inspection readiness, data integrity, training compliance, and the effective operation of end-to-end quality systems, in line with global standards, regulatory expectations, and internal policies.
• Compile and analyze quality metrics, and support Management Review reporting
• Coordinate and prepare Annual Product Quality Review (APQR) reports
• Support document control, QMS maintenance and artwork review processes
• Support inspection readiness activities, including preparation for internal audits and regulatory inspections (e.g., Health Authorities, Notified Bodies)
• Coordinate and track responses to inspection observations, ensuring timely closure
• Review and approve change controls, ensuring compliance with regulatory expectations
• Support Data Integrity initiatives and promote compliance with ALCOA+ principles
• Ensure adherence to GMP, ISO 13485, MDSAP, EU MDR, and local regulatory requirements (e.g., HSA)
• Identify opportunities for continuous improvement in quality systems

Requirements:

• Degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or related field
• Minimum 2 years of experience in Quality Assurance or Compliance in the pharmaceutical and/or medical device industry
• Knowledge of GMP and ISO 13485 quality systems, Regulatory frameworks (e.g., HSA, EU MDR, MDSAP) and Data integrity principles (ALCOA+)
• Able to start work immediately or within short notice

[email protected]

Subject: QA Associate

EA Personnel: Kate Leau Wei Xuan (R1552331)

Company Registration No.: 99C4599