The opportunity
The AMT Proofreading, Quality Control Specialist position is a seasoned proofreading position responsible for reviewing pharmaceutical package component labeling artwork for accuracy in accordance with the Artwork Management System Instructions, Regulatory Affairs Labeling draft, FDA CFR Labeling Regulations and Teva Graphic Standards.
How you’ll spend your day
– With little or no direct supervision, utilizing the electronic proofreading systems, review labeling artwork files for compliance with Teva Graphic Standards, instructions and Regulatory Affairs Labeling draft. – Manually review labeling artwork to ensure dimensional accuracy and format of labeling content. – Independently prioritize work, interact and collaborate with other AMT colleagues, Regulatory Affairs, Package Engineering, Packaging sites, and external component suppliers, respond to and resolve issues as directed to meet established schedules.- Manage the proofreading of third-party artworks, the proxy approvals for technical review, vendor proof review and uploading into the AMT artwork management system of all required documentation. – Assist in the training of new hires to the Proofreading position and ensuring all ‘Train with Trainer’ and other required curriculum items (SOPs, Work Instructions and Teva requirements) are completed and documented within the LMS system. – Collaborates with other Proofreaders to ensure the schedule is maintained. – Communicates any potential issues to the AMT group and to management in a timely manner.- Interact and collaborate with other AMT colleagues, Regulatory Affairs, Package Engineering, Packaging sites, and external component suppliers, respond to and resolve issues as directed in a professional manner to meet established schedules.- The incumbent is experienced on all Proofreading processes and is responsible for all activities required by the Proofreading team. – Responsible for the creation or editing of Reports with the AMT artwork management system to generate metrics and to facilitate the tracking of projects
Supply Chain
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