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Quality Control Specialist

3 weeks ago

Singapore MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD Full time
Job Description:

The Laboratory Information Management System (LIMS) Specialist will be responsible for providing subject matter expertise in LIMS and SAP S4 HANA integration. This role requires a deep understanding of laboratory software and data integrity requirements.

Responsibilities:
  • Subject Matter Expert for Laboratory Information Management System (Labware LIMS)
  • Responsible for LIMS master data configuration for integration with SAP S4 HANA.
  • Responsible for configuration of master data for QC laboratory instrument Preventative Maintenance (PM) / Calibration (CAL) Work order in SAP.
  • Authors cross-functional qualification documents e.g. Risk assessment, User acceptance testing (UAT) and Qualification Summary report and conduct UAT testing in validation environment and release to production.
  • Execute laboratory changes such as Labware LIMS updates and test method changes.
  • Handle change/enhancement request, working closely with Global LIMS team to improve existing workflow in LIMS.
  • Provide guidance, coaching and training to the team for laboratory change in LIMS.
  • Support initiatives for continuous improvement in QC processes related to Lot (Raw Materials, IPC, FP) management, Standard and reagent inventory, Environmental Monitoring, Stability program and QC Instrument/ Equipment PM /CAL management in LIMS/ SAP system with QC system team.
  • Authors and/or revise SOP, protocols and reports.
  • Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and Data integrity requirements.

Requirements:
  • 3 years of experience in quality control within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements.
  • Bachelor's or Master's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology
  • Diploma in Applied Chemistry, Chemical & Pharmaceutical Technology, Pharmacy Science or related and 6+ years of relevant experience in the biotechnology or pharmaceutical industry.
  • Advance knowledge and experience in Labware LIMS
  • Advance knowledge and experience in SAP S4 HANA
  • Process oriented thinking and knowledge in integrating Laboratory software with SAP ERP module.
  • Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements.
  • Good understanding of good laboratory practices, good documentation practice and data integrity requirements.