QC Associate
2 weeks ago
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 - Apple.lim@manpower.com.sg
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
Tell employers what skills you have
Pharmaceutical Industry
Staffing Services
Information Management
Raw Materials
Biotechnology
Biology
SAP
LIMS
SAP ERP
Regulatory Requirements
Life Sciences
Reagent
Laboratory
Manufacturing
Calibration
Work Order
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