Quality Control Operations Scientist
External
Nusantara Prime Consulting · SingaporePrepare for this interview
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About the role
Job Responsibilities: - System Configuration: Develop and maintain LIMS/LES applications (e.g., LabWare, Biovia) to support laboratory workflows. -Workflow Optimization: Collaborate with laboratory personnel to analyze, map, and improve business processes, translating them into digital solutions. - Validation & Compliance: Perform system validation, execute test scripts, and maintain documentation to ensure regulatory compliance. -User Support & Training: Provide technical support, troubleshooting, and training for laboratory staff, DS and DP on system usage. -Instrumentation Interfacing: Configure LIMS and instrument middleware to automate data transfer. -Management of test samples in LIMS/LES: In-process and release samples, environmental testing samples and drug substance and excipient samples -Configure Stability sample in LIMS. -Configure Regulatory retain sample in LIMS -Configure Reference sample in LIMS -Responsible for all other electronic system application, including but not limit to LIMS, EMPOWER and LES. -Ensure all the activities in QC team performed with compliance of cGMP, data integrity and EHS requirement. -To carry out any other tasks assigned by the reporting manager Job Requirements: -Bachelor degree or above in pharmacy, chemistry, biochemistry, analytical chemistry or other related discipline -With NLT 2 years in biotech or biopharma -Deep understanding of FDA, EMA, ICH related regulations -A good understanding of the overall view of drug development process. -A thorough understanding of the principles and management of cGMP compliance, and strong quality minds. -Comprehensive knowledge in FDA, EMA,NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoeias. - Comprehensive knowledge in IND/IMPD,NDA and ANDA filing Contract Duration: 12 months, subject to renewal, based on performance
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