Responsible Person UK

Category: Pharma/Biotech/Clinical Research

Location:

• EnsuringCompliance: The Responsible Person shall ensure that the wholesale distributionactivities carried out under the Wholesale Dealer's License comply with allapplicable laws, regulations, and guidelines related to the distribution,storage, and transportation of medicinal products
• Quality ManagementSystem: The Responsible Person shall establish and maintain an effectivequality management system for the wholesale distribution activities to ensureproduct quality and integrity are maintained at all times
• Record Keeping: The Responsible Person shallmaintain accurate and up-to-date records of all wholesale distributionactivities, including the receipt, storage, and supply of medicinal products
• Product Returns andRecalls: The Responsible Person shall manage product returns and recalls inaccordance with the relevant procedures and guidelines established by SMO UK
• ReportingObligations: The Responsible Person shall promptly report any suspected productdefects, incidents, or other significant issues related to the quality andsafety of the distributed products to SMO UK and MHRA as required by law
• Audits andInspections: The Responsible Person shall cooperate with the MHRA or any othercompetent authority concerning audits or inspections related to the wholesaledistribution activities conducted under the Wholesale Dealer's License
• Training andQualification: The Responsible Person shall ensure that personnel involved inwholesale distribution activities are appropriately trained and qualified fortheir respective roles
• ContinuousImprovement: The Responsible Person shall actively participate in continuousimprovement initiatives to enhance the effectiveness and efficiency of thewholesale distribution activities
• The RPi isresponsible for reviewing and approving import documentation, monitoring thequality of imported products, and investigating any complaints or qualityissues. The RPi also provides support with regulatory inspections

Requirements

Qualificationand Experience

Qualification

• Graduate qualification in Scientific, pharmaceutical,or related field

Experience

• The Responsible Person must have experience in thepharmaceutical industry

Skills, Knowledge, and Special Qualities

• Must be able to demonstrate that they have theknowledge and skills necessary to carry out their duties
• The ResponsiblePerson must also be able to work independently and be able to make decisions

Benefits

Details