QC Analyst IV

1 week ago


Singapore Novartis Singapore Full time

Overview
QC Analyst IV role at Novartis Singapore. Execution of assigned tasks in the quality control laboratory in accordance with cGxP regulations. Performance of laboratory specific activities such as analyses, maintenance, calibration and qualification of analytical equipment.
Key Responsibilities
Sample storage and management
Analytical testing and documentation of API / drug substance / drug product / finished product / complaints / stability / packaging material samples
Ensure all activities in compliance with cGxP, incl. data integrity
Stability (when not centralized)
Testing / Sample storage and management
Analytical documentation of stability samples to cGxP standards
Comply with all HSE guidelines
Detect and report potential accident, risks and propose solutions
Participate in initial training and retraining
Able to support rotating shift hours (Day/night)
Role Requirements
Essential Requirements
Preferred: Previous experience working in a laboratory environment in the pharmaceutical industry (quality assurance, production), aseptic technique
Administrative activities and GMP and HSE-compliant, efficient production and documentation of standardized tasks in the infrastructure
Breakthrough Analysis; Being Resilient; Operational Excellence; Continuous Learning; Digital & Tech Savvy
Laboratory equipment; Quality Control (QC) Testing; Quality Control Sampling; knowledge of TQM and related industry GxP standards and processes; Laboratory Excellence; Quality decision making
Ensure proper maintenance of QC IPC/DS lab equipment and systems to ensure full cGMP-compliance as part of shift team
Perform product testing and analysis under cGMP to meet required timelines
Provide technical support to run and validate necessary test methods on lab equipment and in developing method


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