Job Description Summary
This role will be responsible to establish and ensure testing of drug substance release and stability testing including testing of intermediates in process control samples and lab operations are accordance with written testing SOP’s and local/international regulations.
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Job Description
- 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
- Detect and report potential accident, risks and propose solutions
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
Desirable Requirements:
- University degree or equivalent experience in Pharmacy or Chemistry or equivalent + 0-4 years working experience
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Skills Desired
Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management