LIMS Validation Analyst | CSV & GMP Expert

GMP TECHNOLOGIES (S) PTE LTD; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

GMP Technologies (S) Pte Ltd invites a QA-focused LIMS specialist to support the technology refresh, validation and documentation for the Laboratory Information Management System. You will work with site users and global developers to harmonise methods and workflows.

Responsibilities include drafting validation docs, performing verification, and training staff on new LIMS processes, while ensuring GMP compliance across the lab environment.

Qualifications

• Degree in chemistry or related life-science field.
• 1–2 years in analytical/QC lab, GMP/GxP preferred.
• Experience supporting LIMS upgrades or tech refresh projects.
• Familiarity with CSV validation and related docs (URS, test scripts).
• Knowledge of GMP, data integrity and 21 CFR Part 11/Annex 11.

Responsibilities

• Support LIMS refresh, implementation and validation per site rules.
• Prepare, review and support approval of validation documents.
• Gather lab requirements and draft LIMS templates.
• Collaborate with global developers and site users on workflows.
• Review templates against workflows; identify gaps and feedback.
• Verify and test LIMS templates for lab use.
• Support CSV/validation activities (URS, tests, risk docs).
• Develop SOPs and training materials for new LIMS processes.
• Conduct user training and enable compliant lab practices.
• Assist change initiatives with Site Implementation Manager.
• Coordinate IQ/OQ of instruments connected to LIMS.
• Manage project timelines and escalate blockers.

Skills

LIMS implementation

CSV validation

GxP compliance

21 CFR Part 11

Data integrity

Stakeholder management

Project coordination

Education

Degree in Chemistry / Analytical Chemistry / Pharmaceutical Science / Life Sciences

Tools

Sapphire LIMS

Job description

GMP Technologies (S) Pte Ltd invites a QA-focused LIMS specialist to support the technology refresh, validation and documentation for the Laboratory Information Management System. You will work with site users and global developers to harmonise methods and workflows.

Responsibilities include drafting validation docs, performing verification, and training staff on new LIMS processes, while ensuring GMP compliance across the lab environment.