System Specialist (LIMS Master Data)

We are looking for a Quality Control Specialist to support laboratory operations with a strong focus on master data management within the Laboratory Information Management System, LIMS. The role will be responsible for creating, maintaining, reviewing, and updating master data to ensure accurate test methods, specifications, sampling plans, product information, and laboratory workflows are reflected correctly in the system.

Responsibilities:

• Manage and maintain QC master data within LIMS, including test methods, specifications, product codes, sample templates, analysis profiles, limits, calculations, and approval workflows.
• Support master data creation, revision, and retirement in accordance with approved change control procedures and GMP requirements.
• Review and verify LIMS master data changes to ensure accuracy, completeness, and alignment with approved specifications, methods, SOPs, and regulatory requirements.
• Assess the impact of master data changes on laboratory processes, sample testing, result entry, reporting, and batch release activities.
• Perform user acceptance testing for new or revised LIMS configurations and ensure issues are documented, tracked, and resolved.
• Support LIMS-related investigations, deviations, CAPAs, and change controls where master data or system configuration is involved.
• Ensure compliance with GMP, GDP, data integrity principles, and internal quality procedures.
• Assist in the preparation and review of SOPs, work instructions, and training materials related to LIMS master data management.
• Support audits and inspections by providing documentation, change records, testing evidence, and master data traceability when required.

Requirements:

• Diploma or Degree in Chemistry, Pharmaceutical Science, Biotechnology, Life Sciences, or a related discipline.
• Prior experience in a Quality Control laboratory environment within pharmaceutical, biotechnology, medical device, or other GMP-regulated industries.
• Experience with LIMS master data management, system configuration, or LIMS change requests will be highly preferred.
• Good understanding of QC laboratory testing processes, specifications, test methods, sampling plans, and batch release requirements.
• Knowledge of GMP, GDP, data integrity, change control, deviation, and CAPA processes.
• Strong attention to detail with the ability to review complex data accurately.