Healthcare Quality Assurance Specialist

Healthcare Quality Manager

This is a critical role in driving compliance and quality programs for healthcare transportation & facilities. The position supports the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

• Quality Policies & Procedures: Develop, implement & promote policies and procedures for company's network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP, and others.

• Quality Assessment & Standards: Create and review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to 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 corresponding training programs, and acts as Super User for eQMS system.

• Internal Audit Programs: Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.

• Certification Audits: Lead various certification audits with relevant regulatory agencies and certification providers across the region.

• 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.

• 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.

• Healthcare Quality Feedback: Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

• Validation Programs: Lead the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.

• Depot Support: Provide secondary / backup support to healthcare specialists for market depots.

Requirements:

• A local pharmacist license is required.

• A minimum of 5-7 years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry in a quality-related role is necessary.

• Experience working in a warehouse environment is desired.

• Competencies in quality assurance / regulatory affairs, customer relationship management, and root cause analysis are essential.

• Experience ensuring compliance according to Goods Manufacturing Practice cGMP, Good Clinical Practices cGCP, Goods Distribution Practice (GDP), and ISO13485 for Medical Devices is required.

• Local certifications in a warehouse and transportation business are also required.

• IATA CEIV certification knowledge would be advantageous but not necessary.

• Conducting external and internal audits for regions is also required.

• A Bachelor's degree in Pharmacy from a reputable local institute in Singapore is mandatory.

• Occasional travel to sites and region warehouses may be required.

Competency:

• Accuracy & attention to detail are crucial for proper compliance to regulatory and standards.

• Problem-solving skills are necessary to support customer issue resolution.

• Planning & organization skills are required to ensure proper audit programs are managed effectively.

• Communication skills are necessary to facilitate engagements with customers and regulatory agencies.

• Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking are also required.

• 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 are essential.

Working Hours: Monday to Friday, 9am-6pm.