
Pharmaceutical Laboratory Specialist
1 day ago
This position involves testing drug substance release and stability, including the examination of process control samples.
It requires adherence to written testing SOPs and international regulations.
Key Responsibilities:
- Sample storage and management.
- Analytical testing and documentation of API / drug substance / drug product / finished product / complaints / stability / packaging material samples.
The role also entails ensuring all activities comply with cGxP, including data integrity.
Responsibilities include testing, sample storage, and management, as well as analytical documentation of stability samples to cGxP standards.
Compliance with HSE guidelines is mandatory.
The role requires accident or risk detection and reporting, along with proposing solutions.
Initial training and retraining participation are expected.
Support for rotating shift hours (day/night) is required.
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.
Maintenance of QC IPC/DS lab equipment for full cGMP compliance is necessary.
Product testing and analysis under cGMP to meet timelines must be performed.
Test method validation on lab equipment, including method execution
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