Healthcare Compliance Specialist

2 weeks ago

Singapore FLINTEX CONSULTING PTE. LTD. Full time
About FLINTEX CONSULTING PTE. LTD.

FLINTEX CONSULTING PTE. LTD. is a leading consulting firm in the healthcare industry, dedicated to providing exceptional quality management services.

Job Title: Healthcare QualityDescription

We are seeking an experienced Healthcare Quality professional to join our team as a Healthcare Quality Specialist. This role will be responsible for driving compliance and quality programs for healthcare transportation & facilities and supporting the Healthcare Quality Management System.

The successful candidate will have at least five years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry, with competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis.

Key Responsibilities:

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

In addition, this position requires occasional travel to sites and region warehouses. You must hold at least a Bachelor's degree in Pharmacy from a reputable local or Australia's institute.

Requirements

To be considered for this role, you should have:

  • Local pharmacist license.
  • At least five years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry.
  • Competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis.
  • Working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP, Good Clinical Practises 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.

This position requires strong attention to detail, problem-solving skills, planning & organization skills, communication skills, project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking.

Salary and Benefits

Our estimated salary for this role is between $80,000 - $120,000 per annum, depending on your level of experience and qualifications. In addition, we offer a range of benefits including health insurance, annual leave, and professional development opportunities.

Please note that the actual salary will be determined based on your individual circumstances and negotiation during the hiring process.

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