Stability/LIMS Quality Specialist

  • Cork
  • Contract 2 years
  • JO-1711-63030_1511353410

Summary

Responsibilities:

  • Deliver a robust Quality Management System to support a flexible, collaborate, multi-skilled teamwork environment.
  • Provide independent quality support, guidance and expertise to ensure the success of each area.
  • Complete stability program activities by participation in such activities as protocol preparation, sample preparation and data management etc.
  • Update Nucleus for all changes and addition of new products.
  • Ensure that Nucleus is maintained and streamlined were possible.
  • Coordinator and communicate the prioritisation of updates and changes in Nucleus to all impacted users.
  • Complete training as required with Nucleus users.
  • Support the review & approval of key quality deliverables including Nucleus LIMS, Change control, trackwise, NOEs, DNs, 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

  • Degree in IT and/or Science, Quality.
  • 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.
  • 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 work independently and fully realize improvement initiatives with minimal guidance.
  • Demonstrated ability to co-ordinate the work of others.
  • Demonstrated ability to drive the completion of tasks.
  • Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
  • Proven decision making capability with full accountability and responsibility

Desired:

  • Evidence of Continuous Professional Development.
  • Evidence of continuous Professional development
  • Preference for lean Six Sigma Yellow Belt


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