Laboratory Systems Lead
RK23326
Contract – 11 months
Meath



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Meath. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



The Laboratory Systems Lead will be responsible for supporting the implementation and configuration of Laboratory Systems. This role will support the laboratory teams for testing of incoming raw materials, in-process, drug substance/drug product, stability samples.



Duties:

• SME on data management systems for instrument control in the laboratories, this includes but is not limited to LIMS, Waters Empower, LabX, Softmax Pro, and other laboratory instrument controlling software.
• Build the Lab IT Systems to support Tech Transfer/Commercialisation and manufacturing of Biologics. Monitor and support the performance of the site Laboratory Systems according to cGMP and Systems Development Life Cycle (SDLC) standards such as change control and document management.
• Responsible for implementing industry best practices specific to Laboratory Systems processes that support sample management, testing and validation.
• Ensure site Laboratory Systems comply with changing requirements and trends in worldwide GMPs.
• Deliver training to relevant personnel on the correct application of the site Laboratory System procedures.
• Pro-actively participate in processes to ensure that the Laboratory Systems continue to function effectively and that improvement/remediation actions are taken such as Change Controls, Documentation Management, CAPAs and Audit Readiness.
• Continuous improvement of the Laboratory Systems - Identifying and building in efficiencies as necessary from a systematic and compliance perspective.
• Provide SME support for general troubleshooting, problem solving, technical direction and guidance to support overall business needs.
• Creates an environment of ‘right first time’ in everything that we do through a focus on principles of lean, including simplification, standard work, visual management and a learning organisation.
• Responsible for timely updates of site achievements and challenges. A collaborative approach, working cross functionally on resolving obstacles to maintain a highly effective and productive functional group.

• Degree qualification in a Technical discipline e.g. (Biochemistry /Chemistry /Engineering).
• At least 2-3 years’ experience in Laboratory Systems.
• Previous experience with configuring, building, maintaining laboratory management systems such as LIMS, LabX, Empower systems
• Have an understanding in analytical methodology (e.g., HPLC, ELISA, Glyco analytic, Bioassays, PCR, capillary electrophoresis, compendial assays).
• Have a working understanding of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation