Quality Control Operations Scientist

Nusantara Prime Consulting Pte. Ltd.; Singapore; Presencial; SGD 67 000 - 100 000; Tempo integral

Resumo da oferta

Nusantara Prime Consulting Pte. Ltd. is seeking a Laboratory IT Systems Specialist to design, implement and maintain LIMS/LES applications to support lab workflows in a GMP environment.

You will validate systems, write test scripts, and ensure regulatory compliance while collaborating with lab personnel to optimize processes and translate them into digital solutions. 12-month contract requiring biotech/biopharma experience and knowledge of FDA/EMA/ICH guidelines.

Qualificações

• Bachelor degree or above in pharmacy, chemistry, biochemistry, analytical chemistry or other related discipline.
• NLT 2 years in biotech or biopharma.
• Deep understanding of FDA, EMA, ICH related regulations.
• Good understanding of the drug development process.
• Thorough understanding of cGMP compliance, and data integrity.
• Knowledge of IND/IMPD, NDA and ANDA filings.

Responsabilidades

• Develop and maintain LIMS/LES applications (e.g., LabWare, Biovia) to support laboratory workflows.
• Collaborate with laboratory personnel to analyze, map, and improve business processes, translating them into digital solutions.
• Perform system validation, execute test scripts, and maintain documentation to ensure regulatory compliance.
• Provide technical support, troubleshooting, and training for laboratory staff on system usage.
• Configure LIMS and instrument middleware to automate data transfer.
• Manage test samples in LIMS/LES: in-process and release samples, environmental testing samples and drug substance/excipient samples.
• Configure Stability sample in LIMS.
• Configure Regulatory retain sample in LIMS.
• Configure Reference sample in LIMS.
• Responsible for all other electronic system applications, including LIMS, EMPOWER and LES.
• Ensure all activities in QC team are compliant with cGMP, data integrity and EHS requirements.
• Carry out any other tasks assigned by the reporting manager

Formação académica

Bachelor degree or above in pharmacy, chemistry, biochemistry, analytical chemistry or other related discipline

Ferramentas

LabWare

Biovia

EMPOWER

Descrição da oferta de emprego

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