Packaging Supervisor

The responsibilities of a Clinical Packaging Supervisor at QCS include:

• Ensure that the quality of packaged clinical trial materials are consistent with the Protocol, IMPD and any other sponsor requirements.


• Create clinical trial packaging documentation including packaging 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, customer, and clinical sites.


• To complete reconciliation and agree with the customer on product disposition, destruction and or returns at the end of study.


• Host and manage customer visits along with the QA Teams.


• Support assigned customer meetings, teleconference, 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 Pharmaceutical Quality Management System in accordance with relevant SOPs and instructions.
  
  Ideally have 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 works.
  
  If you have a passion for Medicine research and Clinical trials, we invite you to apply. Head over to our website to learn more about QCS . www.qmedcs.co.uk