This is a remote position.
· Ensuring Compliance: The Responsible Person shall ensure that the wholesale distribution activities carried out under the Wholesale Dealer's License comply with all applicable laws, regulations, and guidelines related to the distribution, storage, and transportation of medicinal products
· Quality Management System: The Responsible Person shall establish and maintain an effective quality management system for the wholesale distribution activities to ensure product quality and integrity are maintained at all times
· Record Keeping: The Responsible Person shall maintain accurate and up-to-date records of all wholesale distribution activities, including the receipt, storage, and supply of medicinal products
· Product Returns and Recalls: The Responsible Person shall manage product returns and recalls in accordance with the relevant procedures and guidelines established by SMO UK
· Reporting Obligations: The Responsible Person shall promptly report any suspected product defects, incidents, or other significant issues related to the quality and safety of the distributed products to SMO UK and MHRA as required by law
· Audits and Inspections: The Responsible Person shall cooperate with the MHRA or any other competent authority concerning audits or inspections related to the wholesale distribution activities conducted under the Wholesale Dealer's License
· Training and Qualification: The Responsible Person shall ensure that personnel involved in wholesale distribution activities are appropriately trained and qualified for their respective roles
· Continuous Improvement: The Responsible Person shall actively participate in continuous improvement initiatives to enhance the effectiveness and efficiency of the wholesale distribution activities
· The RPi is responsible for reviewing and approving import documentation, monitoring the quality of imported products, and investigating any complaints or quality issues. The RPi also provides support with regulatory inspections
Requirements
Qualification and Experience
Qualification
· Graduate qualification in Scientific, pharmaceutical, or related field
Experience
· The Responsible Person must have experience in the pharmaceutical industry
Skills, Knowledge, and Special Qualities
· Must be able to demonstrate that they have the knowledge and skills necessary to carry out their duties
· The Responsible Person must also be able to work independently and be able to make decisions
Benefits
to be filled