
Senior Quality Assurance Manager
8 hours ago
Job Title: Quality Assurance Specialist
This role will be responsible for ensuring the quality and integrity of drug substance release and stability testing, including testing of intermediates in process control samples.
Key Responsibilities:
- Sample storage and management.
- Perform analytical testing and documentation of API / drug substance / drug product / finished product / complaints / stability / packaging material samples.
- Ensure all activities comply with cGxP regulations, including data integrity.
- Stability testing when not centralized.
- Testing, sample storage, and management.
- Comply with all HSE guidelines.
Requirements:
- 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.
About This 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.
Participate in initial training and retraining. Support rotating shift hours (day/night).
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