Quality Assurance and Validation Engineer for Computerized Systems

Taro Pharmaceutical Industries is looking for a QA IT - Quality Assurance and Validation Engineer for Computerized Systems

Job Description:

• Responsible for implementing validation processes for the company’s computerized systems while adhering to company procedures and regulatory requirements (GMP, 21 CFR Part 11, etc.…)
• Reviewing and approving procedures, change controls, investigations, and freezes for all computer systems.
• Participating in the specification process for new systems or changes to existing systems.
• Conducting risk assessments
• Writing validation documents (in English)
• Participating in the analysis of failures and events in computerized systems.
• Actively participating in audits by regulatory authorities and customers.

Job Requirements:

• B.Sc. in Information Systems Engineering / Industrial Engineering / Computer Science / Quality- Must.
• High level of English – Must
• Software Testing Course - significant advantage
• At least 3 years of experience in one of the following fields: validation of computerized systems / software testing / Software Quality Assurance / Medical Device Verification & Validation.
• Familiarity with GMP procedures
• understanding of 21 CFR Part 11, GAMP5 requirements
• Organizational skills, systemic vision, ability to handle multiple tasks
• Ability to work independently and in a team, excellent interpersonal skills
• Ability to drive interfaces and lead processes
• Proficiency in Microsoft Office software