21305 - IT Quality Assurance (QA) Specialist

Job description:

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

This is a full-time position 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