Job Description

Jobscope:

• Participate and supporting laboratory information management system technology refresh in accordance with site procedures and regulatory requirements, inclusive of writing, reviewing, executing and approval of validation related documentations.
• Responsible to authoring, peer reviewing, owning and performing data gathering and population for the requirement documents required by the central project team to allow templates to get developed by adherence to agreed validation timelines and ensure accuracy of validation documents contents.
• Actively engage in method harmonisation with the central developers and site business process flow.
• Providing real time feedback and identifying any errors whilst templates are in development by comparing against existing ways of working (i.e. sapphire or laboratory worksheets) to ensure there is minimal rework and ensuring templates are developed in a timely manner.
• Completing formal verification of the final templates to ensure they are suitable and fit for use in the analytical laboratory.
• Develop and train new, efficient, and compliant working practices, creating supporting procedures and training packages to enable best practices to be quickly embedded.
• Deliver local business change initiatives driven by the Site Implementation Manager (SIM).
• Managing own workload to agreed deadlines, highlighting any blockers and providing solutions in a timely manner to the SIM.
• Work with site instrument maintainer in executing IQ/OQ for all instruments that are connected to new LIMS.

Requirements:

• Degree in Chemistry, Analytical Chemistry, Pharmaceutical Science, Life Sciences or related field.
• Min 1-2 years of experience in analytical/QC laboratory operations, preferably in a GMP/GxP environment.
• Experience with LIMS implementation, upgrade or migration projects.
• Familiarity with Sapphire LIMS or similar laboratory systems is an advantage.
• Experience in CSV/validation, including URS, test scripts, risk assessments and related documentation.
• Good understanding of GMP, data integrity and 21 CFR Part 11 / Annex 11.
• Experience with analytical laboratory instruments and instrument qualification (IQ/OQ).
• Ability to understand laboratory workflows and translate them into LIMS requirements and templates
• Experience in SOP preparation, user testing and training.
• Good communication and stakeholder management skills, with ability to work with local and global teams.
• Strong attention to detail and ability to manage timelines and deliverables.



To find out more about this opportunity, please contact Fiona Koh; fiona.koh@gmprecruit.com

We regret that only shortlisted candidates will be notified.

GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh | Registration No: R1109239