Healthcare Quality Assurance Specialist

1 week ago

Singapore Flintex Consulting Pte Ltd Full time
Job Description:

A highly skilled Healthcare Quality Assurance Specialist is sought after by Flintex Consulting Pte Ltd to drive compliance and quality programs for Healthcare Transportation and facilities. This role will support the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Key Responsibilities:
  • Determine, implement & promote policies and procedures for company 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.
  • Provide inputs to support the design & implementation of robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.
  • Lead and support various certification audits with relevant regulatory agencies and certification providers across the region.
  • Lead regular audit programs / random checks 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 support in issue resolution via conducting root cause analysis (depot).
  • Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.
  • Lead and support validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.

Requirements:
  • Hold local pharmacist license (and may be required to hold licenses and permits on behalf of the company)
  • Have three (3) to five (5) years of relevant experience in pharmaceutical or healthcare industry in a quality related role
  • 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, IATA CEIV and other local certifications in a warehouse and transportation business.
  • Experience in conducting external and internal audits
  • Must hold at least Bachelor's degree in Pharmacy from a reputable local institute.

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