Healthcare Compliance Professional

2 days ago

Singapore beBeeQuality Full time $90,000 - $120,000

Healthcare Quality Specialist

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This role is responsible for driving compliance and quality programs across healthcare transportation & facilities, supporting the healthcare quality management system to ensure processes and systems are compliant with regional and local regulations and customer requirements.

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Key Responsibilities:

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  • '
  • Determine, implement, and promote policies and procedures for company's network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP, and others.">
  • Write and review SOPs and work instructions for transportation & fulfillment solutions pertaining to the healthcare industry.">
  • Implement compliance and quality programs to support local quality teams to ensure they are kept up-to-date and prepared.">
  • 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.">
  • Develop, implement, and support the system and processes, develop corresponding training programs, and act as super user for eQMS system.">
  • Provide inputs to support the design and implementation of robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies and customer audits.">
  • Lead and support various certification audits with relevant regulatory agencies and certification providers for the depot.">
  • Lead regular audit programs/random checks to achieve successful audit outcomes and proper post-audit follow-up actions.">
  • 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 (depot).">
  • Liaise, consolidate feedback from different functions to update and prepare final copy for quality questionnaires, agreements, and RFQ proposals for customers.">
  • Lead and support validation of transportation lanes and critical equipment like cold chain facilities and packaging systems.">
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Requirements:

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  • Have competencies in quality assurance/regulatory affairs/customer relationship management and root cause analysis.">
  • Have working experience ensuring compliance in accordance with Goods Manufacturing Practise cGMP,/ Good Clinical Practices cGCP, Goods Distribution Practice (GDP) for Medical Devices and other local certifications in a warehouse and transportation business.">
  • IATA CEIV will be desired but not necessary.">
  • Familiar with drugs control and secondary labelling system.">
  • Experience in conducting external and internal audits.">
  • Must hold at least Bachelor's degree in Pharmacy from a reputable local institute.">
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Working Hours:

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Monday to Friday 9am-6pm

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