Job Summary:
Our client is seeking an experienced Digital Quality Lab System Implementation Specialist to join our team their digital quality team in Oxford, UK. The ideal candidate will be responsible for overseeing and assisting in the successful implementation of all digital lab system equipment for Quality laboratory operations, ensuring all digital equipment and systems meet GxP standards. This role will also involve the integration and implementation of systems such as LIMs, LES, Clinical Data Management Systems (CDMS) and Scientific Data Management System (SDMS) playing a key role in ensuring digital systems across all lab functions are optimized and compliant with relevant regulatory requirements.
Responsibilities:
- Lead implementation, of digital quality lab systems across all lab functions, ensuring compliance with GxP standards for digital equipment.
- Collaborate with cross-functional teams to ensure integration and transition of processes, including the integration of systems such as LIMs, LES, CDMS and SDMS.
- Implement and ensure the compliance of all digital lab equipment with GxP requirements, including calibration, validation, and data integrity.
- Conduct system configuration and customization
- Ensure that all digital equipment, LIMS, LES, CDMS, and STMS meet regulatory standards (e.g., GMP, ISO, 21 CFR Part 11, GxP) during the implementation process.
- Work closely with the IT team to ensure effective data migration, with attention to maintaining GxP-compliant data integrity across CDMS and STMS systems.
- Support the testing phase of the new system, including validation, UAT, and resolving any GxP related issues in the digital systems or digital equipment.
Qualifications:
- Proven experience in implementing digital quality lab systems in a life sciences environment
- Familiarity with digital quality lab systems
- Experience with laboratory operations, processes, and GxP compliance requirements for digital equipment and systems.
- Experience with system configuration, testing, and validation in a GxP compliant environment.
- Familiarity with specific digital lab systems (e.g., LabWare, LIMS, Labvantage, CDMS and STMS.) You do not need experience with all these.
- Instrumentation engineering background is a plus
- Ability to image and add a PC is a plus
- Some basic networking experience is a must
- Relevant experience outweighs degree, degree doesn’t need to be in a specific field.
EU: Digital Lab Systems Implementation Consultant (236976)