Analytical Support Officer (LIMS) (6 months contract) - Pharma MNC - West - URGENT

GMP TECHNOLOGIES (S) PTE LTD; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

GMP Technologies (S) Pte Ltd in Singapore seeks an experienced LIMS Validation Specialist to support system refreshes, authoring and validating templates, and harmonising methods with central teams. You will ensure data integrity, regulatory compliance, and timely delivery of validation documentation.

The role requires a degree in Chemistry or related field and 5+ years in GMP/QC labs, with Sapphire LIMS experience preferred.

Qualifications

• Degree in Chemistry, Analytical Chemistry, Pharmaceutical Science, Life Sciences or related field.
• 5+ 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.

Responsibilities

• Participate and support laboratory information management system technology refresh in accordance with site procedures and regulatory requirements.
• Authoring, peer reviewing, owning and performing data gathering and population for requirement documents for templates and validation timelines.
• Engage in method harmonisation with central developers and site processes.
• Provide real time feedback and identify errors while templates are developed.
• Complete formal verification of final templates for suitability and use in the analytical lab.
• Develop and train new, efficient, compliant working practices and procedures.
• Deliver local business change initiatives driven by the Site Implementation Manager (SIM).
• Manage workload to deadlines and coordinate with SIM.
• Work with site instrument maintainer on IQ/OQ for instruments connected to new LIMS.

Skills

LIMS knowledge

GxP awareness

Data integrity

Education

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

Tools

Sapphire LIMS

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.
• 5+ 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 .

We regret that only shortlisted candidates will be notified.

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