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Data Integrity Specialist

2 weeks ago

Singapore beBeeQualification Full time $80,000 - $115,000
Job Title: Quality Control System Specialist About the Role:

We are seeking a highly skilled Quality Control (QC) system specialist to support our laboratory digitalisation efforts. The ideal candidate will have strong hands-on experience in Laboratory Information Management Systems (LIMS), specifically in master data setup and management.

Key Responsibilities:
  • Lead the setup, configuration, and maintenance of LIMS master data, including test methods, specifications, sample plans, materials, and workflows.
  • Collaborate with QC, IT, and validation teams to support LIMS implementation, upgrades, and ongoing system support.
  • Ensure data integrity, compliance, and adherence to Good Manufacturing Practice (GMP) and ALCOA+ principles across QC systems.
  • Troubleshoot system issues, perform change control, and participate in periodic reviews of system performance.
  • Support user requirement gathering, UAT, and system documentation aligned with regulatory expectations.
  • Provide training and end-user support for QC staff on LIMS functionalities and workflows.
  • Act as Subject Matter Expert (SME) for QC digital systems and contribute to laboratory digitalisation projects and initiatives.
  • If applicable, support integration and data transfer between LIMS and Empower for chromatographic data management.
Requirements:
  • Degree in Life Sciences, Chemistry, or a related field.
  • Minimum 3–5 years of experience in pharmaceutical QC with a focus on LIMS systems and master data management.
  • Proven track record of working with LIMS platforms (e.g., LabWare, LabVantage, Thermo Fischer SampleManager, etc.).
  • Familiarity with Empower CDS (e.g., method setup, data review) is a plus.
  • Understanding of GMP, Data Integrity (DI), and regulatory requirements in QC operations.
  • Strong communication and documentation skills, with the ability to work cross-functionally with IT, QA, and QC stakeholders.