An opportunity has arisen within a Cork based biopharmaceutical multinational for a Satbility Quality Specialist. The successful candidate will provide Quality support and expertise to the labs and ensure supply of quality pharmaceutical products in meeting the Compliance, Supply, Strategy and Profit plan.
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
QUALIFICATIONS & EXPERIENCE
· Degree in IT and/or Science, Quality.
· 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.
· Good analytical and technical skills.
· Demonstrated change management skills with continuous improvement.
· Demonstrated use of Leadership Behaviours
· Knowledge and experience in interpreting current applicable regulatory requirements and providing independent Instrumentation and validation to the site.
· Demonstrated ability to drive the completion of tasks.