Our client is looking for an Artwork Coordinator to own all the implementation activities required to create and maintain a compliant and controlled web based PPM change control management system & library.
Essential Duties and Responsibilities include the following:
- Manage, monitor and update the printed packaging material (ppm) assets in the change management system library.
- Manage, monitor and update the printed packaging material (ppm) attributes in the change management system library, checking accuracy with the packaging sites.
- Add and delete ppm assets to the system following a procedure – performing and document monthly reviews on any artwork and its attributes that is older than three years to ensure it is still in use and still compliant.
- Operate in partnership with the administrators to create or modify workflow templates as required by the business, by implementing and testing the proposed changes through the change control process.
- Perform any user acceptance testing tasks for software upgrades.
- Work in partnership with the UK and US based Regulatory Specialists supporting any admin functions required by them in high workload periods, such as workflow generation, translation coordination and any other support documentation generation.
- Perform self inspections and system audits.
In addition, the chosen candidate will also be expected to fulfil the following requirements:
- Strong working knowledge of cGMP guidelines.
- Good organizational skills, prioritization and planning skills.
- Good interpersonal and communication skills.
- Attention to detail is essential as this is a highly regulated and procedure based role.
- Strong computer skills in particular Word and Excel.
- Ability to work independently and deliver results with minimal supervision.
- Team player.
- Multitask orientated.
- Ability to use Adobe Acrobat.
- Mindset for process improvement.
- IT bias.
- Knowledge and understanding of 21CFR Part 11.
- Ability to make infrequent local trips to the SDS office and other Elanco facilities.
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