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The Lead provides support to client departments, in particular Quality Control and Manufacturing.
·Map, develop and configure LIMS and EBR (electronic batch record)
workflows and facilitate utilisation to support QC and Manufacturing operations, including reporting, enabling operational process efficiencies.
·Implement, deploy and maintain the LIMS in close collaboration with, and in order to support the operational functions of, the QC Department in line with GxP.
·Maintain system related databases and ensure practices and procedures for data archiving, back-up, restore and system recovery are in-line with policies, GxP guidelines and regulations.
·Develop LIMS solutions for processes by system configuration and LIMS BASIC programming.
·Work with QC and Manufacturing teams to define IT system needs and assist with selection of software, such as LIMS and electronic batch records (EBR) and supporting hardware.
·Work with vendors, IT, laboratory staff and QA to procure and implement IT systems.
·Lead CSV lifecycles and ensure compliance with current policies, GxP guidelines and regulations
·Act as point of contact for issues and maintain system relevant issue logs as required.
·Take responsibility for integrating systems, e.g., LIMS with laboratory instruments and other corporate applications.
·Keep up-to date with IT advancements and champion recommendations for existing system upgrades and new cutting-edge systems to improve and develop operations.
·From time to time, provide system and maintenance support outside of normal business hours to ensure operational continuity.
·Participate in the scoping, evaluation and implementation of other new lab-based IT systems.
·Lead change control on lab-based IT systems.
·Participate in the maintenance of the computer system validation master plan and the validation of individual systems.
·Experience working in a lab-based environment, particularly QC.
·Minimum 2-3 years LIMS administration experience.
·Minimum BSc in a science or computer science discipline.
·Experience in writing and executing deliverables for CSV to comply with GxP guidelines.
·Demonstrable experience of working in a GxP environment.
·Demonstrable knowledge of data integrity implications in regulated environments.
·Experience with QA systems, procedures and change controls.
·Experience in interfacing QC equipment with LIMS.
·Experience in managing IT projects and working with IT system maintenance functions.
·Technical experience in supporting and troubleshooting IT systems, particularly Microsoft Azure, and MS SQL.
·Competency in Microsoft applications including SharePoint, Word, Excel, and PowerPoint.
·Working knowledge and practical experience of GAMP5 an advantage.
·Understanding of basic programming and relational databases.