Label Specialist

S E C Recruitment Limited
09 Mar 2018
15 Mar 2018
Contract Type
Full Time
Technical responsibilities - Label Processes * 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.

Other attributes
* Deliver excellent customer service and consistently strive to meet commitments to customers and optimize operational effectiveness.
* Positively contribute to key label design and production metrics to optimize the global Label Group model.
* Contribute to continuous improvement initiatives and support internal GMP audits and GMP facility/process inspections, where applicable.

* Good set of GCSE's, or equivalent, including Mathematics and English (grades A-C).

* 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.
* Working with cross functional teams; communicating a requirement to review and approve / reject documentation.
* Acting upon requests to amend / change information.

* Label design and production experience.
* Experience using Clinicopia or other label software.
* Experience working in a Clinical supply chain

Technical Ability
* Attention to detail; ability to work with accuracy; adaptable to changing priorities.
* Able to work with autonomy and self-organisation; to work in a very busy environment.

* Computer literacy in Microsoft WORD, Excel, PowerPoint and Outlook (e-mail).
* Experience with use of SharePoint.

* Motivated by team environment.
* Self motivated to complete work on schedule with 100% accuracy; to deliver to challenging timelines.
* Keen and willing to learn new skills, and share knowledge with others.

Personal Characteristics
* Excellent communication skills.
* Approachable and friendly and effective in a team environment.
* Willing to learn from others and share knowledge.
* Adheres to high standards, and always focuses on customers.

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