Engineering and Computerized Systems QA Specialist

Engineering and Computerized Systems Quality Professional Lead

An opportunity to join a leading biopharmaceutical company in a key role in the fields of quality, engineering, and computerized systems.

A central position serving as a key interface point between the Quality, Engineering, and IT departments, and includes professional responsibility for validation processes, control, and changes in an advanced regulatory environment.

Job Description and Responsibilities:

• Approval of validation documents for computerized systems, process control systems, and engineering (URS, VP, FS, TRM, STR, STD, STP, IQ, OQ, PQ)
• Approval of validation and changes for computerized applications (hardware and software), equipment, and infrastructures
• Accompaniment and approval of writing procedures and specifications
• Assistance in formulating policy on computing and software topics, including Risk Assessment management and performing GAP Analysis
• Participation in evaluation of new software, definition of GMP requirements and definition of user requirements
• Accompaniment of engineering projects as a Quality representative
• Accompaniment, responsibility, and approval of validation deviations on behalf of QA

Job Requirements:

• Bachelor’s degree in Engineering or Science – mandatory
• Hebrew and English at a high level – mandatory
• Experience in writing validation documents for computerized systems – advantage
• Ability to work with multiple interfaces and lead processes in a multi-interface environment
• Experience from the pharmaceutical or medical device industry – significant advantage
• Familiarity with GMP Annex 11 and 21 CFR Part 11 – advantage
• Experience working with IT departments (infrastructure, applications, ERP systems) - advantage