Careers

Responsibilities:

• 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.

Job Qualification & Requirements

• 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.

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