about 1 month ago
Ready to move into your next role as Technical Specialist supporting the internal commercial QC labs in the Global AS&T with responsibility for leading a multi-site team. If you are a spectacular technical specialist who wants to take the next step working at an amazing global biologics manufacturing company then keep reading!
This is a contract of 12-months (full-time) based in North Dublin .
What will you do in this job?
- Develop/maintain processes/user workflows in lab systems to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met.
- Collaborate with appropriate laboratory, manufacturing, analytical support and/or site/global IT teams to ensure needs and requirements are accurate in the lab systems.
- Review method/specification change controls, identify lab system impact, and develop appropriate change actions required to support implementation of the change, including impact to interfacing systems.
- Author, revise, and/or review procedural documents, such as SOPs and WIs and associated training content.
- Contribute to strategy for deployment across sites in conjunction with relevant teams (Enterprise IT Lab Systems, ITBPs, QC, etc.).
What do you need to be successful in this job?
- Minimum BS, preferably Masters in biological science or related field with at least 1-3 years of experience in biopharmaceutical technical operations.
- Strong scientific background in analytical methods and processes related to biopharmaceutical bulk and finished products preferred.
- Demonstrated knowledge or experience in use, development and/or management of Lab Data Systems, preferably in the MODA Lab Data System, to understand impact of changes to these systems and integrations.
- Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices.
The next step for you:
Interested in this role? Please send your CV to CHLOE DONEGAN at Next Generation Recruitment by clicking on the Apply button!
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