About the Role:
We are looking for a QC System Specialist with strong hands-on experience in LIMS (Laboratory Information Management Systems), specifically in master data setup and management. You will be supporting laboratory digitalisation efforts, ensuring data integrity, and enabling smooth system implementation and ongoing maintenance. Experience with Empower CDS is a strong advantage.
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 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 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.