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Quality
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049390 Requisition #
SGS is the world’s leading inspection, verification, testing and certification company.

One of the business segments, SGS Life Sciences, is a leading contract research organization (CRO) providing drug development and post-approval services to the pharmaceutical and biopharmaceutical industry.

Within the Clinical Pharmacology Unit in Antwerp we are looking for a (m/f)

Clinical Trial Pharmacist

Responsibilities:

The Clinical Trial Pharmacist is handling Investigational Medicinal Products in a Clinical Trial Environment. The specific tasks for the Pharmacist will be:
• Act as the primary Pharmacy contact to clients and the clinical trial team
• Provide IMP and trial medication expertise / support
• Perform IMP handling
o IMP receipt, accountability, storage, dispensing and manufacturing activities
o Set-up of pharmacy related documents
o Set-up of IMP labels in line with sponsor and regulatory requirements
• Define and follow-up corrective action plans towards deviations
• Developing, implementing and evaluating processes and procedures to ensure overall compliance of the Pharmacy services

Additionally, this Clinical Trial Pharmacist may take up the responsibility of the Qualified Person, such as
• Quality control of IMP at CPU (procedures, subcontractors, training, self-inspections)
• Control of incoming IMP materials (specification, testing, approval)
• Batch release (compliance of batch records and environmental specifications, specifications, storage conditions, reference samples, etc)
• Certification of manufactured batches
• Import and release IMP from outside EU to be used in clinical trials (ensure EU GMP manufacturing, certification of authorization documents, control of manufacturer information, QC analysis, release of IMP, keeping reference/retention samples)
• Control of storage and use of IMP in clinical trials

Key Competencies:
* University degree in pharmaceutical sciences.
• Sense for structure, precision and accuracy
• Planning / Organization / Problem Solving / Teamwork / Leadership
• Fluent Dutch and English
• Quality driven

Interested or do you know somebody who might be?

Please apply online with your motivation letter and resume via http://jobs.sgs.com


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