Healthcare Regulatory and Quality Specialist

A global provider of transportation, e-commerce and business services is seeking a Healthcare Regulatory and Quality Specialist to drive compliance and quality programs for Healthcare Transportation & Facilities and to support the Healthcare Quality Management System to ensure processes and systems comply with regional and local regulations and customer requirements.

• 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.

• Bachelor's degree in Pharmacy from a reputable local institute and hold a local pharmacist license.
• Have three to five years of relevant experience in the pharmaceutical or healthcare industry in a quality-related role
• Experience working within a warehouse environment is highly desired
• 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
• 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

• Associate

• Full-time

• Quality Assurance, Other, and Supply Chain

• Transportation, Logistics, Supply Chain and Storage

Location: Johor Baharu, Johore, Malaysia