QC Analyst III

3 days ago

Singapore NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING PTE. LTD. Full time

Job Description
This role will be responsible for establishing and ensuring testing of drug substance release and stability testing, including testing of intermediates in process control samples. Lab operations must comply with written testing SOPs and local/international regulations.
About the Role:
Execution of assigned tasks in the quality control laboratory in accordance with cGxP regulations. Performance of laboratory 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 comply with cGxP, including data integrity.
Stability testing 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 accidents or risks and propose solutions.
Participate in initial training and retraining.
Support rotating shift hours (day/night).
Role Requirements:
Essential Requirements:
Preferred: Previous experience in a pharmaceutical laboratory environment (quality assurance, production), aseptic techniques.
Administrative activities and GMP/HSE-compliant documentation of standardized tasks.
Knowledge of TQM, industry GxP standards, laboratory equipment, QC testing, sampling, and quality decision-making.
Ensure proper maintenance of QC IPC/DS lab equipment for full cGMP compliance.
Perform product testing and analysis under cGMP to meet timelines.
Support and validate test methods on lab equipment, including method

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