Summary
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.
About The Role
Key Responsibilities:
Operational
- 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
HSE
- Comply with all HSE guidelines
- Detect and report potential accident, risks and propose solutions
- Responsible for participating in initial training and retraining
Essential Requirement
- Preferred: Previous experience working in a laboratory environment in the pharmaceutical industry (quality assurance, production), aseptic technique.
- Collaboration; result-oriented
- 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
- Must be willing to work in 12hrs rotational shift.
Desirable Requirement
- Completed apprenticeship as a laboratory assistant or equivalent training
- Basic (oral and written) in English; fluent in local language (oral and written)
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