Healthcare Compliance Specialist

2 weeks ago

Singapore FLINTEX CONSULTING PTE. LTD. Full time
Job Title: Healthcare Compliance Specialist

Estimated Salary: SGD 80,000 - 120,000 per annum

FLINTEX CONSULTING PTE. LTD. is seeking a highly skilled and experienced Healthcare Compliance Specialist to join our team.

The successful candidate will be responsible for driving compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Key Responsibilities:

  • Determine, implement & promote policies and procedures for company's Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others.
  • Write & review SOPs and Work Instructions for transportation & fulfilment 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 & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.
  • Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.
  • Lead various certification audits with relevant regulatory agencies and certification providers across the region.
  • Lead & prepare for regular audit programs / random checks / regulatory activities 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 resolve issues via conducting root cause analysis.
  • Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.
  • Lead the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.
  • Provide secondary / backup support to healthcare specialists for market depots.

Requirements:

  • Hold local pharmacist license.
  • Have at least five (5) years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry.
  • Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis.
  • Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices, IATA CEIV and other local certifications in a warehouse and transportation business.
  • Experience in conducting external and internal audits for regions.
  • Must hold at least Bachelor's degree in Pharmacy from a reputable local or Australia's institute.
  • This position require to communicate with counter part in China.
  • Occasionally travel is required to sites and region warehouses.

Competency:

  • Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards.
  • Problem-solving skills to support customer issue resolution.
  • Planning & organization skills to ensure proper audit programs are managed effectively.
  • Communication skills to facilitate engagements with customer and regulatory agencies.
  • Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking.
  • Apply data-driven decision making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint.

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