Quality Assurance Specialist Healthcare

6 days ago

Singapore beBeeQuality Full time $90,000 - $120,000
Job Title: Healthcare Quality Manager

 

The role of the Healthcare Quality Manager is to drive compliance and quality programs for Healthcare Transportation & Facilities and support the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

 

Key Responsibilities:

  • 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.
  • Write & 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 & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.
  • Design & 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.
  • 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.

 

Requirements:

  • Hold a degree in Pharmacy or related field.
  • 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 desirable.
  • 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 Practices cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices.
  • Experience in local certifications in a warehouse and transportation business.

 

Competency Requirements:

  • 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:

Monday to Friday, 9am-6pm

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