Healthcare Operations Compliance Manager

2 weeks ago

Singapore beBeeCompliance Full time $80,000 - $100,000
Healthcare Quality Specialist Role

We are seeking a highly skilled and experienced specialist to drive compliance and quality programs for our healthcare transportation and facilities. This role is critical in supporting the development and implementation of our Healthcare Quality Management System.

Key Responsibilities:
  • Determining, implementing, and promoting policies and procedures for our network and facilities to ensure compliance with regional and local regulations and customer requirements.
  • Writing and reviewing standard operating procedures (SOPs) and work instructions for transportation and fulfillment solutions pertaining to the healthcare industry.
  • Implementing compliance and quality programs to support local Quality teams and ensuring they are kept up-to-date and prepared.
  • Leading process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitoring action progress until closure.
  • Developing, implementing, and supporting our Healthcare Quality Management System, including developing corresponding training programs, and acting as Super User for eQMS system.
  • Providing inputs to support the design and implementation of robust internal audit processes to ensure readiness of various functions and processes when meeting regulatory agencies and customer audits.

You will work closely with our team to ensure that our operations meet the highest standards of quality and compliance.

Requirements:

To be successful in this role, you will need to have:

  • A local pharmacist license.
  • 3-5 years of relevant experience in pharmaceutical or healthcare industry in a quality-related role.
  • Competencies in quality assurance/regulatory affairs/customer relationship management and root cause analysis.
  • Working experience ensuring compliance in accordance to Goods Manufacturing Practice cGMP, Good Clinical Practices cGCP, Goods Distribution Practice (GDP) for Medical Devices and other local certifications in a warehouse and transportation business.
  • IATA CEIV is desired but not necessary.
  • Familiarity with drugs control and secondary labeling system.
  • Experience in conducting external and internal audits.
  • A minimum of Bachelor's degree in Pharmacy from a reputable local institute.

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