12 month contract with global leading pharma company for a Labelling Specialist.
A specialist in the design, initiation, approval and production of labels intended for clinical trial supplies. The Label Specialist will create labels for internal production and label content for the subsequent transfer of labels for external production.
* Engage with the Packaging Coordinator to understand the label design requirements for a clinical study.
* As a subject matter expert, using Global procedures, design individual labels using label software for clinical trial supplies; create the labels in the requested languages and ensure they meet the requirements as defined in the Label Request documents and the country specific Regulatory Templates.
* Liaise with the Phrase Library Administrator and Packaging Coordinator to request the translation for any phrase that is not currently available in the Phrase Library to enable the design of labels.
* Initiate completed label designs to the appropriate approval groups.
* Liaise with the approval groups to expedite the approval of the label designs and make necessary amendments to the labels if requested to do so.
* Complete second verification checks on label content and design.
* Create PDF files of approved labels for export to external label vendors.
* Work with the Packaging Coordinator to generate print requests for approved label designs for internal label production, where applicable.
* Print and inspect labels.
* Prepare labels for shipment to other locations, where applicable.
* Print blinding disclosure sheets following submission of an approved request * Monitor usage of label media and inform Group Lead or delegate of re-order levels.
* Collaborate with Internal Packaging Coordinators to generate Purchase Orders for vendor produced labels.
* Relevant industry experience: working to Good Manufacturing Practice (GMP) standards and compliance with Standard Operating Procedures (SOP) * Functionality that may include designing or formatting documents.
* Label design and production experience.
* Experience using Clinicopia or other label software.
* Experience working in a Clinical supply chain
Job Title: Label Specialist
Reference No: 238572
Job Type: 12 months
- regulatory affairs
- clinical supplies