The Healthcare Responsible Person (RP) is responsible for GDP compliance in the Branches that hold WDA licenses with the relevant Regulatory Authorities. This job description will refer to the EU GDP Guideline (2013/C 343/01).
The RP supports the district and its employees to comply with GDP requirements. The RP is also responsible for following-up all aspects of GDP compliance and related corrective actions.
Recommendation: The time allocated to this role should reflect the level of GDP business at the district.
- The RP should fulfil their responsibilities personally and should be continuously contactable. The RP may delegate duties but not responsibilities. Employ due diligence in the discharge of their duties, maintaining full compliance to procedures and appropriate regulations.
- Ensure there is there a clear understanding with the DRP relating to the delegation of duties within the district.
- 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.
- Where outsourced activities are required, approve any subcontracted activities which may impact on GDP.
- Apply the appropriate transport requirements and methods for cold chain, ambient and hazardous product · Ensure all transport equipment is appropriately qualified.
- Ensure that transactions or activities are only made with brokers who are registered.
- Ensure compliance with agreed customer requirements as documented in the Customer SOP
- The RP is the designated person responsible for Active Pharmaceutical Ingredients (API) & Active Substance Registration (ASR), as per Directive 2011/62/EU (Falsified Medicines Directive)
- 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.
- Job Execution: Consistently completes quality work that matches job expectations. Is committed to operational excellence and continuous improvement for own job function and across the network. All activities are compliant with company policies/procedures and code of business conduct and with government regulations.
- Reliability: Consistently meets deadlines. Is punctual and can be relied on for planning purposes. Is organized, manages own time effectively and can prioritize.
- Collaboration: Displays a willingness to accomplish not only his/her own job responsibilities without the need for constant prodding but is willing, without request, to aid and assist others to the benefit of the company and/or customers. Works in harmony with superiors and fellow workers without incident or delay.
- Communication: Effectively listens to others and communicates (verbal and written) in a professional manner, both internally and externally. Provides relevant and timely information to co-workers, customers and service providers. Answers phone calls and responds to voicemails, emails and other communication according to Expeditors' standards.
- Culture: Exhibits and promotes the company’s 10 cultural attributes: Appearance, Attitude, Confidence, Curiosity, Excellence, Integrity, Pride, Resolute, Sense of Humour, and Visionary.
Healthcare Responsible Person (RP) Job-Specific Competencies
- Quality Management System (QMS) Manage the QMS to ensure it is proportionate to the distributor’s activities is implemented and maintained. Manage risk in accordance with GDP requirements. Follow procedures for change control. Measure GDP compliance performance sharing results in Management Reviews. Follow procedures for change control. Measure GDP compliance performance sharing results in Management Reviews.
- Operational Process Standards (OPS) Expeditors’ Operational Process Standards (OPS) are in place to ensure we are providing consistent and quality services to our customers. RP’s must maintain a thorough working knowledge of the latest GDP OPS versions, guiding our employees to meet our documented standard processes and identification of where there may be risk to the quality of our services being provided to our customers.
- Manage District GDP Compliance : Communicate local and standard GDP requirements within the district identifying required actions according to GDP standards as documented in the Operational Process Standards (OPS). Define employee role responsibilities and accountabilities, recording all delegated duties. Ensure delegation of duties to other Regional Compliance Managers or Deputies in the event of absence. This delegation can be communicated through the “out of office” messaging system or by other means of documented communication.
- Expeditors Owned or Leased Premises : Identify healthcare products, legal categories, storage conditions and different Marketing Authorization types. Maintain the safety and security of healthcare products within the appropriate environments, including product integrity and product storage. Use the appropriate systems to segregate, store and distribute healthcare products. Maintain records for the repair, maintenance, calibration, and validation of equipment including computerized systems. Ensure storage areas are temperature mapped, qualified, and validated.
- Manage GDP Document Control: Ensure accurate and good quality records are contemporaneously recorded. Written procedures are documented, understood, and followed. Record storage. All current version documents are to be used, recorded, and retained in compliance with OPS and local regulations. The use of Expeditors systems enforced as standard practice.
- Operations Engagement: Carry out due diligence checks and ensure that suppliers and customers are qualified. Ensure all necessary checks are carried out and that healthcare products are authorized for sale. Manage authorized activities to ensure operations do not compromise the quality of healthcare products and can demonstrate compliance with GDP. Demonstrate the application of activities and provisions in accordance with the wholesale distribution authorization and of company processes and procedures. Ensure that any additional requirements imposed on certain products by national law are adhered to e.g., specials, unlicensed imports & controlled drugs.
- Complaints, returns, suspected falsified medicinal products and medicinal product recalls Ensure relevant customer complaints are dealt with effectively, informing the manufacturer and/or marketing authorization holder of any product quality/product defect issues. Co-ordinate and promptly perform any recall operations for healthcare products. Co-operate with marketing authorization holders and national competent authorities in the event of recalls. Have an awareness of the issues surrounding falsified medicines.
- 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 publishes the results of all internal and external audits.
- GDP Training: Complete GDP required trainings within the defined timeline as defined on the Healthcare / GDP Training Map in the PDC. Coordinate the assignment of the GDP role in the PDC to applicable employees. 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, communicate any and all instructions as they relate to our network. Coordinate implementation of Quality Technical Agreements and Service Level Agreements, collaborating with the Healthcare group and Expeditors legal department for approval.
- GDP Service Provider Management: Ensure GDP Service Provider profiles are maintained in CRM, compliant to Expeditors standards. Manage the use of GDP approved Service Providers where applicable, as per the Customer instruction. Conduct routine and for cause Service Provider audits as applicable.