Quality Assurance Specialist

Qualitest, the World’s Leading AI-Powered Quality Engineering Company

At Qualitest we're all about ensuring everything runs smoothly, whether it's your business, technology, or operations. We leverage smart engineering-led practices and precise processes to maintain excellence in all that we do.

Our clients are the world’s top brands and our diverse global team of 8,000 employees, including 1,500 in Israel, collaborates with industry leaders in technology, finance, insurance, and beyond, making a significant impact in the world of technology.

We offer creative and flexible solutions to ensure the quality of your business operations, safeguarding your brand's reputation. We're proud to say we've been pushing the boundaries for over 25 years now, always striving for innovation and delivering exceptional service.

Ready to make a difference? Join our dynamic and forward-thinking team!

We’re seeking an IT Quality Assurance (QA) Specialist for an exciting and challenging position on our team!

This is a part-time position (50%) in Beersheba

Responsibilities:

• Support QA oversight of computerized systems used in GxP-regulated environments (e.g., manufacturing, quality, supply chain, clinical, pharmacovigilance).
• Review and approve validation deliverables, including URS, risk assessments, validation plans, test protocols, deviation reports, and validation summaries.
• Ensure compliance with relevant regulations and guidelines, including GxP, 21 CFR Part 11, EU Annex 11, and data integrity principles.
• Participate in system implementation, upgrades, changes, and periodic reviews from a quality perspective.
• Perform QA assessments of IT processes such as change management, incident management, access control, backup and recovery, and vendor management.
• Support internal and external audits and inspections related to computerized systems.
• Collaborate closely with IT, CSV, business stakeholders, and external vendors.
• Contribute to the continuous improvement of QA and validation processes and procedures.
• Support SOP authoring, review, and maintenance related to IT quality and validation.

Requirements:

• Bachelor’s degree in Life Sciences, Computer Science, Engineering, or a related field - Must3–6 years of experience in QA, CSV, or IT Quality within a pharmaceutical or other regulated industry - Must
• Hands-on experience with computerized system validation (CSV) - Must
• Experience working in a GMP/GxP environment -Must
• Strong knowledge of regulatory requirements: GxP, 21 CFR Part 11, EU Annex 11, data integrity (ALCOA+) - Must
• Familiarity with common pharmaceutical IT systems (e.g., ERP, QMS, LIMS, MES, clinical or PV systems) is an advantage.
• Understanding of SDLC and risk-based validation approaches - Must
• Strong attention to detail, analytical thinking, and documentation skills - Must
• Ability to work independently and collaboratively in a cross-functional environment - Must
• Good communication skills in English, both written and verbal- Must

Why should you join us?

• Recognized among Israel's top 100 best places to work for, four years in a row
• Be 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