Clinical Packaging Supervisor
Posted 13/05/2024 by CHR Life Sciences
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'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
- Type:
- Permanent
- Start Date:
- Immediate
- Contract Length:
- N/A
- Contact Name:
- Login or register to view
- Job Reference:
- LGCPS
- Job ID:
- 221644492
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