We're seeking an IT Quality Assurance (QA) Specialist for an exciting and challenging position on our team! As a QA Specialist, you will be responsible for ensuring compliance with relevant regulations and guidelines, including GxP, 21 CFR Part 11, EU Annex 11, and data integrity principles.
Requirements
- Bachelor’s degree in Life Sciences, Computer Science, Engineering, or a related field
- 3–6 years of experience in QA, CSV, or IT Quality within a pharmaceutical or other regulated industry
- Hands-on experience with computerized system validation (CSV)
- Experience working in a GMP/GxP environment
- Strong knowledge of regulatory requirements: GxP, 21 CFR Part 11, EU Annex 11, data integrity (ALCOA+)
- Familiarity with common pharmaceutical IT systems (e.g., ERP, QMS, LIMS, MES, clinical or PV systems)
- Understanding of SDLC and risk-based validation approaches
- Strong attention to detail, analytical thinking, and documentation skills
- Ability to work independently and collaboratively in a cross-functional environment
- Good communication skills in English, both written and verbal
Benefits
- Recognized among Israel's top 100 best places to work for, four years in a row
- Part of a company that is a globally recognized leader in Quality Engineering
- Experience our team spirit, working with real people, and solving real challenges
- Work with Senior Specialists and Practice Experts
- Nurture your personal and professional growth through tailored career paths
- Dive into interesting projects using cutting-edge technology designed by and for Quality Engineers
- Enjoy unique placement opportunities worldwide
- We believe in a workplace culture that values open communication and fairness, encouraging our employees to feel seen, supported, and empowered to realize their full potential