LIMS ADMINISTRATOR required by CareerWise Recruitment for our multinational biopharma client in Co. Cork. Two year Fixed Term Contract on offer. The LIMS ADMINISTRATOR will provide Quality support and expertise to the laboratories and ensure supply of quality pharmaceutical products in meeting the Manufacturing Division priorities of: Compliance, Supply, Strategy and Profit plan. THE ROLE: * 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. * Makes decisions within guidelines and policies which impact QC projects. REQUIREMENTS: * 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. * 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. * Preference for lean Six Sigma Yellow Belt. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999. CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times. This job originally appeared on RecruitIreland.com.
104 days ago