Healthcare Quality Assurance Specialist
5 days ago
We are seeking a seasoned professional to join our team at FLINTEX CONSULTING PTE. LTD.
Job SummaryThe successful candidate will play a critical role in driving compliance and quality programs for our 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.
Key Responsibilities- Determine, implement, and promote policies and procedures for company's Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP, and others.
- Write and review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.
- Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.
- 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.
- Develop, implement, and support the system and processes, develop corresponding training programs, and act as Super User for eQMS system.
- Design and implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.
- Lead various certification audits with relevant regulatory agencies and certification providers across the region.
- Lead and prepare for regular audit programs / random checks / regulatory activities to achieve successful audit outcomes and proper post-audit follow-up actions.
- 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.
- Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements, and RFQ Proposals for customers.
- Lead the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.
- Provide secondary/backup support to healthcare specialists for market depots.
- Hold local pharmacist license.
- Have at least five (5) years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry.
- Have competencies in quality assurance / regulatory affairs, customer relationship management, and root cause analysis.
- Have working experience ensuring compliance in accordance with Goods Manufacturing Practise cGMP, Good Clinical Practices 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 for regions.
- Must hold at least Bachelor's degree in Pharmacy from a reputable local or Australia's institute.
- This position requires communication with counterparts in China.
- Occasional travel is required to sites and region warehouses.
- Accuracy and attention to detail, which is crucial to proper compliance to regulatory and standards.
- Problem-solving skills to support customer issue resolution.
- Planning and organization skills to ensure proper audit programs are managed effectively.
- Communication skills to facilitate engagements with customers and regulatory agencies.
- Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile, or Design Thinking.
- 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.
$80,000 - $100,000 per annum, depending on experience.
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