Healthcare Quality & Regulatory Specialist
Flintex Consulting
Full-time
On-site
Singapore, Singapore, Singapore
Auditing, Regulatory, Quality, and Compliance
This role is responsible to drive 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.
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1. Quality Policies & Procedures:<\/span>
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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:<\/span>
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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:<\/span>
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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:<\/span>
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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:<\/span>
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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:<\/span>
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Provide inputs to support the design & implementation of 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:<\/span>
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Lead and support various certification audits with relevant regulatory agencies and certification providers for the depot.<\/span>
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8. Operations & Customer Audit Programs:<\/span>
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Lead regular audit programs \/ random checks to achieve successful audit outcomes and proper post audit follow up actions.<\/span>
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9. Healthcare Customer Liaison:<\/span>
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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).<\/span>
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10. Healthcare Quality Feedback:<\/span>
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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:<\/span>
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Lead and support validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems<\/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 3\-5 years of relevant experience in pharmaceutical or healthcare industry in a quality related role<\/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) for Medical Devices and other local certifications in a warehouse and transportation business.<\/span>
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5. IATA CEIV will be desired but not necessary.<\/span>
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6. Familiar with drugs control and secondary labelling system<\/span>
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6. Experience in conducting external and internal audits<\/span>
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7. Must hold at least Bachelorâs degree in Pharmacy from a reputable local institute.<\/span>
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Working hours:<\/u><\/b><\/span>
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Mon to Fri 9am\-6pm<\/span><\/span>
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