Analytical Support Officer (LIMS) (6 months contract) | Pharma MNC

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

About the role

Participate in and support 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.

Job Responsibilities

• Support the Laboratory Information Management System (LIMS) technology refresh, implementation and validation in accordance with site procedures and regulatory requirements.
• Prepare, review, execute and support approval of validation documentation for the LIMS project.
• Gather laboratory requirements and prepare/review requirement documents for development of new LIMS templates.
• Work closely with central/global developers and site users on method harmonisation and laboratory workflow requirements.
• Review developing LIMS templates against existing laboratory workflows and worksheets, identify gaps/errors and provide timely feedback.
• Perform formal verification and user testing of completed LIMS templates to ensure they are fit for use in the analytical laboratory.
• Support CSV/validation activities, including URS, test scripts, risk assessments and related validation documentation.
• Develop/revise SOPs, procedures, work instructions and training materials for new LIMS processes.
• Conduct user training and support implementation of new compliant laboratory working practices.
• Support local business change initiatives and work closely with the Site Implementation Manager and relevant stakeholders.
• Coordinate with instrument maintenance teams to support IQ/OQ of analytical instruments connected to the new LIMS.
• Manage assigned project timelines and deliverables, escalating blockers and proposing solutions where required.

Requirements

• Degree in Chemistry, Analytical Chemistry, Pharmaceutical Science, Life Sciences or related discipline.
• Minimum 1–2 years of analytical/QC laboratory experience, preferably within a pharmaceutical GMP/GxP environment.
• Hands-on experience supporting LIMS implementation, upgrade, migration or technology refresh projects.
• Familiarity with Sapphire LIMS or similar laboratory systems will be advantageous.
• Experience in Computer System Validation (CSV) and validation documentation such as URS, test scripts and risk assessments.
• Good understanding of GMP, data integrity and computerized-system compliance, including 21 CFR Part 11 / Annex 11.
• Experience with analytical laboratory instruments and instrument qualification (IQ/OQ).
• Able to understand analytical laboratory workflows and translate them into LIMS requirements/templates.
• Experience in SOP preparation, user testing, validation documentation and user training.
• Comfortable working with local and global cross-functional teams.
• Strong attention to detail with good communication, stakeholder management and project coordination skills.
• Able to manage timelines independently and work in a fast-paced project environment.

GMP Technologies (S) Pte Ltd | EA License: 11C3793 | EA Personnel: Dianna| Registration No: R1327268

We regret that only shortlisted candidates will be notified.