The LIMS Administrator - Quality Specialist will provide Quality support and expertise to the laboratories and ensure supply of quality pharmaceutical products in meeting the priorities of : Compliance, Supply, Strategy and Profit plan.
Duties and Responsibilities:
•Deliver a robust Quality Management System to support a flexible, collaborate, multi-skilled teamwork environment.
•Update LIMs for all changes and addition of new products.
•Ensure that LIMs is maintained and streamlined were possible.
•Coordinate and communicate the prioritisation of updates and changes in LIMS to all impacted users.
•Complete training as required with LIMs users.
•Support the review & approval of key quality deliverables including LIMS, Change control, trackwise, Deviations, CAPAs. Etc.
•Review & approval of GMP procedures (& associated documents) for the lab
•Participation in inspection of site by CQAC/Regulatory Bodies /third parties.
•Champion the highest quality and compliance standards for the laboratories.
•Makes decisions within guidelines and policies which impact QC projects.
•Champion the highest Quality and Compliance standards for QC labs.
•Degree in Science, Quality or IT related discipline.
•Knowledge on software
•Good analytical and technical skills.
•Demonstrated change management skills (CEM) with continuous improvement.
•At least 3-5 years’ experience in the Pharmaceutical industry or a similar operating environment, with a strong emphasis on QC systems, in particular LIMS.
For a confidential discussion and more information on the role, please contact Rory Walsh.