Cache of job #13832392

Job Title

Stability And Lims Quality Specialist

Employer

Morgan Mckinley

Location

Cork

Description

Stability and LIMS quality specialist required for a leading pharmaceutical company in Cork. The roles involves providing quality support and expertise to the laboratories and ensuring supply of quality pharmaceutical product. Job Responsibilities: Deliver 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. Makes decisions within guidelines and policies which impact QC projects. Champion the highest Quality and Compliance standards for QC labs. Education and Experience required: Degree or third level qualification in Science. Minimum of 3 years experience in the Pharmaceutical industry. Good analytical and technical skills. Demonstrated change management skills (CEM) with continuous improvement. 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 realise improvement initiatives with minimal guidance. Six Sigma yellow belt is desirable. Morgan McKinley is acting as an Employment Business in relation to this vacancy. Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide. This job originally appeared on RecruitIreland.com.

Date Added

2320 days ago

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