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 ScopeQuality 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.
Quality Assessment & Standards:
Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.
Compliance & Quality Program Management:
Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.
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.
Healthcare Quality Management System:
Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.
Internal Audit Programs:
Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.
Certification Audits:
Lead various certification audits with relevant regulatory agencies and certification providers across the region.
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.
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.
Healthcare Quality Feedback:
Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.
Validation Programs:
Lead the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.
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.
- 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
Mon to Fri 9am-6pm
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