Stability Quality Specialist

  • Cork
  • Temporary 12 months
  • JO-1901-64115_1546939725

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 LIMs for all changes and addition of new products.
* Ensure that LIMs is maintained and streamlined were possible.
* Coordinator and communicate the prioritisation of updates and changes in to all impacted users.
* Complete training as required with LIMs users.
* Support the review & approval of key quality deliverables including LIMS, Change control, trackwise, NOEs, DNs, CAPAs. Etc.
* Review & approval of GMP procedures (& associated documents) for the lab
* Participation in inspection of site by 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.

Required:
* Degree in IT and/or Science, Quality
* Knowledge on software
* Good analytical and technical skills.
* Demonstrated change management skills with continuous improvement.
* At least 3 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 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

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