My Client is a global provider of transportation, e-commerce and business services. You will be critical in driving compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems comply with regional and local regulations and customer requirements.
What you'll do:
- Quality Policies & Procedures:
Determine, implement & promote policies and procedures for the internal Network and facilities (hubs & stations) to ensure compliance with standards such as GDP, GCP and others. - Quality Assessment & Standards:
Write & review SOPs and Work Instructions for transportation & fulfilment solutions in 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 related training programs, and acts as Super User for the eQMS system. - Internal Audit Programs:
Provide inputs to support the design & implementation of robust internal audit processes to ensure the readiness of various functions & processes when meeting regulatory agencies & customer audits. - Certification Audits:
Lead and support various certification audits with relevant regulatory agencies and regional certification providers. - Operations & Customer Audit Programs:
Lead regular audit programs / random checks 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 support in issue resolution via conducting root cause analysis (depot). - Healthcare Quality Feedback:
Liaise and consolidate feedback from different functions to update and prepare the final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers. - Validation Programs:
Lead and support validation of transportation lanes and critical equipment like cold chain facilities and packaging systems.
What you'll need:
- Five to ten years of relevant experience in the pharmaceutical or healthcare industry in a quality-related role
- Bachelor's degree in relevant disciplines
- Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis
- Have working experience ensuring compliance with 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
Competencies:
- Accuracy & attention to detail which is crucial to proper compliance with 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