Healthcare Quality & Regulatory Specialist ( APAC) - Bukit Merah
FLINTEX CONSULTING PTE. LTD. Bukit Merah Permanent
Position Summary
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.
Job Scope- Quality Policies & Procedures: Determine, 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: Write & 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 :
- Hold local pharmacist license
- Have at least 5 -7 years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry in quality related role
- Experience working in warehouse is desire
- Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis
- Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices,
- Experience in 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 institute in Singapore.
- Occasionally travel is required to sites and region warehouses.
- Accuracy & attention to detail which is crucial to proper compliance to 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
Working hours:
Mon to Fri 9am-6pm
MOH HoldingsBukit Merah
ORGANISATION / DIVISION INFORMATION
As the holding company of Singapore’s public healthcare institutions, we are always looking for qualified, passionate individuals who are keen to make a valuable contribution to public healthcare...
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Position Summary
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