Healthcare Quality & Regulatory Advisor

Job Description

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 and have good understanding on cold chain compliance
• 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,
• Experience in conducting external and internal audits for Japan warehouse in healthcare industry
• This role is to be based in Osaka, Japan.

Competency

Working hours : Mon to Fri 9am-6pm

Requirements

Healthcare Quality & Regulatory Advisor