• Posted: 02/08/2023
  • Salary: Good day rate
  • Location: Manchester, United Kingdom
  • Job Type: Contract
Key Responsibilities:
  • Responsible for maintaining the WDA License and ensuring that variations are made to the license as required. Perform RP duties as per GDP guidelines.
  • Provide QA oversight of all GDP activities in accordance with local requirements; ensure product procurement, storage and distribution are managed in accordance with GDP requirements.
  • Provide advice to senior management when required and must have personal knowledge of all the relevant GDP guidelines.
  • Proactively partner with other commercial departments to ensure quality aspects of new launches are properly handled. Set up effective collaborations with functional areas such as Regulatory, Supply Chain, local country manager.
  • Lead local affiliate Management Reviews.
  • Provide guidance and monitor quality issues related to products and GDP to resolution within the company and with external parties.
  • Raise and review documentation including change controls, deviations, CAPAs, SOPs and specifications relating to distribution activities. Provide training if required.
  • Responsible for conducting self-inspection as per schedule and audits of external suppliers.
  • Maintain, review and update Standard Operating Procedures for Quality Assurance and Distribution related activities ensuring compliance with GDP regulations.
  • Ensure Quality Technical Agreements are in place for all outsourced activities.
Joe Lane Director

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