Compliance Specialist for Healthcare Transportation

7 days ago

Singapore beBeeQuality Full time

Healthcare Quality Specialist

We are seeking a skilled Healthcare Quality Specialist to join our team. In this role, you will be responsible for driving compliance and quality programs for healthcare transportation & facilities and supporting the quality management system to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Responsibilities:

  • Determine, implement, and promote policies and procedures for our network and facilities (hubs & stations) to ensure compliance with 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 & 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/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.

Requirements:

  • Hold local pharmacist license.
  • Have 3-5 years of relevant experience in pharmaceutical or healthcare industry in a quality-related role.
  • Have competencies in quality assurance/regulatory affairs, customer relationship management, and root cause analysis.
  • Have working experience ensuring compliance in accordance with Goods Manufacturing Practice 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 labeling 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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