Healthcare Quality & Regulatory Specialist ( APAC)
Flintex Consulting
Full-time
On-site
Singapore, Singapore, Singapore
Auditing, Regulatory, Quality, and Compliance
Position Summary<\/u><\/b>
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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.<\/span>
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Job Scope<\/u><\/b><\/span>
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1. Quality Policies & Procedures: Determine, implement & promote policies and procedures for companyâs Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others.<\/span>
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2. Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.<\/span>
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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.<\/span>
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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.<\/span>
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5. Healthcare Quality Management System: Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.<\/span>
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6. Internal Audit Programs: Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.<\/span>
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7. Certification Audits: Lead various certification audits with relevant regulatory agencies and certification providers across the region.<\/span>
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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.<\/span>
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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.<\/span>
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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.<\/span>
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11. Validation Programs: Lead the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.<\/span>
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12. Depot Support: Provide secondary \/ backup support to healthcare specialists for market depots.<\/span>
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Requirements :<\/u><\/b><\/span>
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1. Hold local pharmacist license<\/span>
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2. Have at least 5 \-7 years of relevant experience in warehouse, quality + QMS for pharmaceutical \/ healthcare industry in quality related role<\/span>
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3. Experience working in warehouse is desire<\/span>
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3. Have competencies in quality assurance \/ regulatory affairs, customer relationship management and root cause analysis<\/span>
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4. Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)\/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices,<\/span>
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5. Experience in local certifications in a warehouse and transportation business.<\/span>
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IATA CEIV certification knowledge would be at advantage but not necessary.<\/span>
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5. Experience in conducting external and internal audits for regions<\/span>
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6. Must hold at least Bachelorâs degree in Pharmacy from a reputable local institute in Singapore.<\/span>
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7. Occasionally travel is required to sites and region warehouses.<\/span>
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Competency<\/u><\/b><\/span>
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1. Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards<\/span>
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2. Problem\-solving skills to support customer issue resolution<\/span>
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3. Planning & organization skills to ensure proper audit programs are managed effectively<\/span>
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4. Communication skills to facilitate engagements with customer and regulatory agencies<\/span>
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5. Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking<\/span>
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6. 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<\/span>
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Mon to Fri 9am\-6pm<\/span>
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