Laboratory Systems Lead Position
About the Role
This is an exciting opportunity to join a leading organization in the Pharmaceutical sector. The successful candidate will be responsible for supporting the implementation and configuration of Laboratory Systems.
Key Responsibilities
* 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.
Requirements
* 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