Healthcare Quality & Regulatory Advisor

Flintex Consulting

  • Singapore
  • Permanent
  • Full-time
  • 6 days ago
Job Description:Position SummaryThis position play a critical role in 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.Job Scope1. Quality Policies & Procedures: 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.2. Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.3. Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.4. 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.5. Healthcare Quality Management System: Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.6. Internal Audit Programs: Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.7. Certification Audits: Lead various certification audits with relevant regulatory agencies and certification providers across the region.8. Operations & Customer Audit Programs: Lead & prepare for regular audit programs / random checks / regulatory activities to achieve successful audit outcomes and proper post audit follow up actions.9. 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 resolve issues via conducting root cause analysis.10. Healthcare Quality Feedback: Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.11. Validation Programs: Lead the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.12. Depot Support: Provide secondary / backup support to healthcare specialists for market depots.Requirements :
  • Have at least 5 -7 years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry in quality related role
  • Experience working in warehouse is desire
  • 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 certification knowledge would be at advantage.
  • Experience in conducting external and internal audits
  • This role is to be based in Guangzhou, China.
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
Working hours:Mon to Fri 9am-6pm

Flintex Consulting