Analytical Support Officer (LIMS) (6 months contract) | Pharma MNC
GMP TECHNOLOGIES (S) PTE LTD
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
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