STABILITY QUALITY SPECIALIST required by CareerWise Recruitment for our multinational pharmaceutical client in Co.Cork.1 year fixed term contract on offer.
The STABILITY QUALITY SPECIALIST will complete stability program activities by participation in such activities as protocol preparation, sample preparation and data management etc.
Role of this position
- 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 Nucleus 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 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 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 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