Clinical packaging supervisor

  • Cv Library
  • London
  •   £35,000 - £45,000
  • posted 24 days ago
  • CV-Library.co.uk

Job description:

CHR Life Sciences is exclusively partnered with a boutique clinical services firm looking to expand. The company, founded in 2015, recently acquired its clinical packaging service license from the MHRA in 2023 and is looking for a supervisor to help build out the function and create a team of operators beneath them. Job Responsibilities: * Ensure the quality of packaged clinical trial materials are consistent with protocol, IMPD and any other sponsor requirements. * Create clinical trial packaging documentation including specification, labels, blinding strategies, randomisation, batch packaging records, dispatch and returns. * Manage timely receipt and release of starting materials, bulk, and components. * Ensure IMPs, NIMPs and Comparators are received and stored according to the SOPs and the sponsor requirements. * Supervise clinical trial packaging operations that include directly working in clinical trial packaging operations when required. * Support timely completion of QP Certification of clinical trial supplies. * Maintain finished goods inventories and ensure timely distribution of trial materials to the clinical sites. * Resolves clinical trial product distribution issues by working closely with couriers, customers and clinical sites * To complete reconciliation and agree with the customer on product disposition, destruction and or returns at the end of the study * Host and manage customer visits along with the QA Teams. * Support assigned customer meetings, teleconferences, and internal meetings. * Customer point of contact for clinical packaging, storage and distribution as assigned. * Manage sourcing and supply of comparator products as required for the clinical trials. * Ensure compliance with the company #39;s Pharmaceutical Quality Management System in accordance with the relevant SOPs and instructions. Qualifications Requirements: * Ideally a degree in Pharmaceutical Sciences, Clinical Supplies, or similar disciplines. * Must have 5+ years on-the-job experience in a clinical manufacturing and or packaging environment. * Have in-depth understanding of clinical trials and supplies. * Knowledge of QMS Quality standards including GMP, GCP and GDP. * Experience in clinical supply field and a contract manufacturing organisation
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