QUALITY ASSURANCE ENGINEER (H/F)

Job description

NALYS is a consulting company developing High-Tech solutions through our Excellence Centers.
We deliver performance and added value by intensively investing our people.
We are currently looking for a motivated consultant specialized in QUALITY ASSURANCE.
As a consultant in the position of QA, you will provide our clients with the necessary expertise and assistance to further improve and maintain the quality standards of their operations and products
Quality assurance engineers monitor the process of manufacturing biotechnology products to ensure that the process is carried out properly and that it is compliant with laws and regulations
- Gather and analyze data, prepare reports and make recommendations for
- Changes and improvements
- Prepare compliance audit
- Implement company standards and government regulations: GMP, ASTM E2500, ICHQ8/Q9/Q10, FDA Guidance
- Monitor rules and standards application, resolve gaps (CAPA, deviation ..)
- Investigate through Root cause analysis tools, perform risk analysis (FMEA..)
- Verify that the equipment is properly installed and maintained.
- Ability to document procedures, work instructions and inspection documents including methods of acceptance.
Ability to perform project management responsibilities, or participate, on continuous improvement teams focused on problem solving, lean initiatives, new product development, supplier selection, and product cost take-out.
REQUIREMENTS:
- MSc degree in BioChemistry
- At least 1 year of demonstrated experience in a QA related position (OQ/IQ/PQ ..).
- Ability to effectively communicate technical information in a clear, concise French and English language (written and verbal) within a GMP-regulated environment.
- Self Organized and methodic mindset
- Details oriented mindset