LIMS Administrator

Summary:
A biopharmaceutical company in West Cork required a GLIMS Administrator.

Responsibilities:

• You will provide Quality support and expertise to the laboratories and ensure supply of quality pharmaceutical products.
• 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.

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.
• Knowledge on software.
• Good analytical and technical skills.
• Demonstrated change management skills (CEM) with continuous improvement.
• Knowledge and experience in interpreting current applicable regulatory requirements and providing independent Instrumentation and validation to the site.
• Demonstrated ability to work independently.
• Stakeholder management of multiple decision makers, auditors and cross functional teams.
• Proven decision making capability with full accountability and responsibility.