Healthcare Responsible Person

Expeditors; Greater London; On-site; GBP 60,000 - 80,000

Job description

We take care of our employees, and they take care of our customers!

Become a member of a global community! The international logistics industry is an integral piece of the global trade puzzle; we make the world go round. Global supply chain management is what we do, and at the heart of Expeditors you will find professionalism, leadership, and a friendly environment, all of which foster an innovative, customer service-based approach to logistics. Expeditors is a global logistics company headquartered in Seattle, Washington. As a Fortune 500 company, we employ over 19,000 trained professionals in a worldwide network of over 350+ locations across six continents. Expeditors satisfies the increasingly sophisticated needs of international trade through customized solutions and seamless, integrated information systems.

Our Mission

We recruit, train, and retain the very best logistics and technical experts the world over. We love to promote from within - more than 50 percent of our employees have been at Expeditors for five years or more. Our high retention rate is influenced by a unique compensation program for positions that are more than just jobs - they're chances to grow, do what you love and build a career with us!

Job Description

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 on 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 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.

Qualifications

• A minimum of 2 years employment at Expeditors and/or relevant Healthcare industry experience.
• University Degree or equivalent business experience.
• GDP Certification (within 6 months of appointment).
• GDP Auditing Certification (within 6 months of appointment).
• Global logistics industry knowledge.
• Prior relevant knowledge and experience related to the distribution of healthcare products.
• Access to pharmaceutical knowledge and advice when it is required.
• Knowledge of the products traded under the license.
• If not a pharmacist or QP, one year's relevant practical and managerial experience of healthcare products.
• The role of Regulatory Authority in the licensing of medicines and as the competent authority including the risk-based inspection process, the role of the Enforcement Group, the Inspection Action Group (IAG) UK, and resulting actions that can be taken due to non-compliance.
• The local regulatory regulations in relation to wholesale distribution.
• The European Pharmaceutical Directive related to wholesale distribution of medicinal products.
• Knowledge and understanding of clear reporting to the wholesale distribution authorization holder, senior manager and/Healthcare Vertical Global Director and Regional Vice President.
• Knowledge and understanding of the Home Office in relation to the handling of controlled drugs.
• Good time management.
• Fluent in English.
• Professional oral and written communication skills in English and in the local language.
• Facilitation & communication skills at all levels.
• Problem solving skills.
• PC skills at advanced level including Microsoft Excel, PowerPoint, and Word.
• Flowchart creation and presentation skills.
• Process analysis skills.
• Auditing skills including advanced questioning skills.
• Competent goal setting skills.

Additional Information

Benefits:

• Competitive salary.
• Pension.
• Private Medical Insurance.
• Stock Purchase Plan.
• Training and Personnel Development Program.