Healthcare Quality & Regulatory Advisor
Flintex Consulting
Full-time
On-site
Guangzhou, Guangzhou, China
Auditing, Regulatory, Quality, and Compliance
Position Summary
This 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 Scope
1. 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