LIMS Validation & Analytics Specialist

GMP TECHNOLOGIES (S) PTE LTD; Singapore; Vor Ort; SGD 70.000 - 110.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

LIMS knowledge

GxP awareness

Data integrity

Ausbildung

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

Tools

Sapphire LIMS

Jobbeschreibung

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.