Compliance Officer (CP-2025-05-01)

Job Purpose

To oversee and ensure compliance with Quality, Environmental, Health, and Safety (QEHS) requirements across operations, with a particular focus on Good Distribution Practice (GDP), SS 620 (Good Distribution Practice for Medical Devices in Singapore), and ISO 13485 (Medical Devices – Quality Management Systems). The role includes maintaining certifications, ensuring regulatory compliance, and supporting continuous improvement efforts.

Key Responsibilities

Quality Management

• Develop, implement, and maintain quality management systems in accordance with GDP, SS 620, and ISO 13485.
• Lead internal and external audits; manage audit findings and corrective/preventive actions (CAPA).
• Ensure quality documentation is controlled, reviewed, and archived according to regulatory standards.
• Train staff on quality requirements and SOPs related to pharmaceutical and medical device distribution.

GDP / SS 620 / ISO 13485 Compliance

• Ensure end-to-end compliance with GDP and SS 620 requirements in storage, handling, and transportation of medical products and devices.
• Maintain relevant licenses, certifications, and regulatory registrations.
• Coordinate validation and qualification activities (e.g., temperature mapping, calibration, equipment qualification).
• Work closely with warehouse and logistics teams to ensure temperature-sensitive goods are managed according to specifications.

Environment, Health & Safety (EHS)

• Monitor and enforce compliance with applicable EHS legislation, codes of practice, and internal policies.
• Conduct risk assessments and recommend control measures.
• Promote safe work practices through campaigns, toolbox talks, and incident investigations.
• Maintain and improve ISO 14001 (Environmental) and ISO 45001 (OHS) systems, if applicable.

Continuous Improvement

• Drive QEHS improvement initiatives across departments.
• Analyse non-conformities, customer complaints, and incidents to prevent recurrence.
• Report key performance indicators (KPIs) and trends to management regularly.

Requirements

Education & Experience

• Diploma in Quality, or related field.
• Minimum 3 years’ experience in a QEHS role with exposure to pharmaceutical, medical device, or life science logistics environment.
• Familiarity with:
  • Good Distribution Practice (GDP)
  • SS 620 (Singapore Standard for medical device distribution)
  • ISO 13485 (Medical device quality management)

Skills & Competencies

• Strong knowledge of QMS principles and regulatory requirements.
• Audit experience (internal and external).
• Attention to detail, analytical mindset.
• Good communication and stakeholder engagement skills.
• Certification in ISO 13485 Lead Auditor / GDP Auditor is an advantage.