LIMS Validation & QC Analytics Specialist

No-Deviation-Pte.-Ltd; Singapore; On-site; SGD 70,000 - 100,000; Full time

Benefits offered by this job

Leave policy

Health & wellness coverage

Professional development opportunities

Inclusive culture

Career growth

Job summary

No-Deviation-Pte.-Ltd. in Singapore is seeking a QC Analytical SME to support the LIMS technology refresh, authoring and reviewing validation documents, and embedding new practices in the analytical lab.

You will own workload and timelines in line with site procedures and regulatory requirements. You will write and review validation materials, participate in method harmonisation with central developers, and verify templates before live use.

Qualifications

• Degree or diploma in Chemistry, Biological Sciences, Pharmaceutical Science or a related field.

Responsibilities

• Participate in and support the LIMS technology refresh in accordance with site procedures and regulatory requirements, including writing, reviewing, executing and approving validation-related documentation.
• Author, peer review and own requirement documents, and gather and populate data for the central project team so templates can be developed within agreed validation timelines
• Engage in method harmonisation with the central developers and site business process flow
• Provide real-time feedback and identify errors while templates are in development, comparing against existing ways of working to minimise rework
• Complete formal verification of final templates to confirm they are fit for use in the analytical laboratory
• Develop and train new, efficient and compliant working practices, creating supporting procedures and training packages
• Deliver local business change initiatives driven by the SIM
• Manage own workload to agreed deadlines, highlighting blockers and proposing solutions to the SIM in a timely manner
• Work with the site instrument maintainer to execute IQ/OQ for all instruments connected to the new LIMS

Education

Degree or diploma in Chemistry, Biological Sciences, Pharmaceutical Science or a related field

Tools

LIMS (Sapphire/gLIMS)

Job description

No-Deviation-Pte.-Ltd. in Singapore is seeking a QC Analytical SME to support the LIMS technology refresh, authoring and reviewing validation documents, and embedding new practices in the analytical lab.

You will own workload and timelines in line with site procedures and regulatory requirements. You will write and review validation materials, participate in method harmonisation with central developers, and verify templates before live use.