Healthcare Compliance Specialist

5 days ago


Singapore beBeeRegulatory Full time $60,000 - $100,000
Job Description

This is a critical role in driving compliance and quality programs for Healthcare Transportation & Facilities and supporting the Quality Management System to ensure processes and systems comply with regional and local regulations and customer requirements.

  • Quality Policy Implementation: Determine, implement, and promote policies and procedures for internal networks and facilities (hubs & stations) to ensure compliance with standards such as GDP, GCP, and others.
  • Quality Assessment & Standards: Develop and review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.
  • Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.
  • CAPA Process Management: Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.
  • Healthcare Quality Management System: Develop, implement, and support the system and processes, develop corresponding training programs, and act as Super User for the eQMS system.
  • Internal Audit Programs: Provide inputs to support the design and implementation of robust internal audit processes to ensure the readiness of various functions and processes when meeting regulatory agencies and customer audits.
  • Certification Audits: Support various certification audits with relevant regulatory agencies and regional certification providers.
  • Operations & Customer Audit Programs: Lead regular audit programs/random checks to achieve successful audit outcomes and proper post-audit follow-up actions.
  • Healthcare Customer Liaison: Liaise with customers to understand quality requirements/issues/underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL, and support in issue resolution via conducting root cause analysis.
  • Healthcare Quality Feedback: Liaise and consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements, and RFQ Proposals for customers.
  • Validation Programs: Support validation of transportation lanes and critical equipment like cold chain facilities and packaging systems.


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