- 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.
- 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
- Evidence of Continuous Professional Development.
- Evidence of continuous Professional development
- Preference for lean Six Sigma Yellow Belt
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The Life Science Specialists