- Building Nucleus LIMS protocols in a GMP environment for all new products.
- Update Nucleus for all changes in a timely manner.
- Reviewing and interpretation GMP test methods for LIMS builds.
- 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.
- Provide LIMS training to all users
- 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.
- Degree in IT and/or Science, Quality.
- Knowledge and experience in building and updating a LIMS system in a GMP environment.
- Knowledge and experience in reviewing and interpretation GMP test methods for LIMS builds.
- 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
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists