Description
The Healthcare Compliance Representative (CR) supports the district and its employees to comply with GDP requirements. The CR is also responsible for following-up all aspects of GDP compliance and related corrective actions.
Responsibilities and Duties
This section lists job-specific tasks and duties, such as the ones listed below, that are completed on a regular basis by the Healthcare Compliance Representative.
• Ensure there is there a clear understanding with the CR Back-Up relating to the delegation of GDP tasks and duties.
• Conduct all GDP tasks as they relate to the district facility type and GDP Customer requirements.
• In Expeditors owned or leased facilities, ensure that facilities and equipment are maintained to GDP standards.
• Take responsibility for ensuring that all risks that may impact GDP activities or customer product are risk assessed.
• Support operations on recalled, returned, quarantined, rejected, or falsified products as per customer instructions.
• Ensure compliance with agreed customer requirements as documented in the Customer SOP
• Manage Corrective Actions and Preventive Actions (CAPA) to ensure that the appropriate actions are documented and implemented correctly and timely.
• Ensure that customers have been informed in writing of any issues with shipments.
• Lead and implement global and regional GDP initiatives in the district.
• Attend conference calls with the Healthcare Regional Team as required.
• Attend the quarterly Management Review Meeting with District Management
• Participate in departmental and other meetings at the district as appropriate to discuss GDP Compliance
• Attend the annual BCP review where contingency plans are applicable.
• Engage with Account Managers of district GDP Customers supporting on GDP quality topics.
Healthcare Compliance Representative Job-Specific Competencies
• Operational Process Standards (OPS)
Expeditors’ Operational Process Standards (OPS) are in place to ensure we are providing consistent and quality services to our customers. CR’s must maintain a thorough working knowledge of the latest GDP OPS versions, guiding our employees to meeting our documented standard processes and identification of where there may be risk to the quality of our services being provided to our customers.
District GDP Compliance
Communicate local and standard GDP requirements within the district identifying required actions according to GDP standards a s documented in the Operational Process Standards (OPS).
• GDP Document Control
Ensure that all current version documents are used, recorded, and retained in compliance with OPS and local regulations. The use of Expeditors systems enforced as standard practice.
• Internal and External GDP Audits
Manage external Customer or Regulatory Audits. Perform self-assessments according to GDP standards as documented in GDP OPS. Communicate and publish the results of all internal and external audits.
• Employee GDP Training
Coordinate the assignment of the ‘GDP’ role in the PDC to applicable employees as noted on the GDP training map. Communicate deadlines for required GDP trainings including refresher training. Escalate GDP training non-compliance to the District Manager and Regional Healthcare Compliance team.
• Customer Service
Oversee onboarding new Healthcare Customers, work with T&I to align the Customer SOP as it relates to Healthcare/GDP. Consider network business as it relates to operations ensuring instructions are documented at a local level. Co-ordinate implementation of Quality Technical Agreements and Service Level Agreements, collaborating with the Regional Healthcare team and Expeditors legal department for approval.
• GDP Service Provider Management
Ensure GDP Service Provider profiles are maintained in CRM and compliant to Expeditors standards. Ensure GDP approved Service Providers are used as per the Customer instruction. Conduct routine and for cause Service Provider audits as applicable.
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