QC Associate (LIMS System Support)
15-Months Contract
Industry : Pharmaceutical
Location: Tuas
Salary up to $6500 depending on experience
Job Summary:
- Subject Matter Expert for Laboratory Information Management System (Labware® LIMS)
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. required.
- 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.
- Support and backup of QC system projects/activities, including laboratory asset lifecycle management, Continuous periodic verification of analytical method and stability program
- Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records related to these tasks.
- Any other duties as assigned by line manager
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.
- Knowledge of the quality systems and associated technologies.
- Good understanding of good laboratory practices, good documentation practice and data integrity requirements.
Lim Pey Chyi - [email protected]
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
