GENAIZ

General

• Work with clients to understand their laboratory operations, including sample handling, equipment usage, and data management
• Collaborate with developers to design and implement AI-powered solutions on the GenAIz Platform
• Provide technical expertise to clients on the implementation and use of our solutions
• Develop and maintain strong relationships with clients to ensure successful project outcomes
• Identify opportunities for new solution development and work with the product team to bring these ideas to life

Solution Specialist

• Perform reviews and verifications of commissioning, qualification, and validation documents for clients' systems and processes
• Coordinate CSV projects for software and automated systems
• Develop validation strategies and plans
• Coordinate activities among stakeholders (IT department, SMEs, end users, quality unit, vendors)
• Perform risk analyses and define the qualification process
• Write and review risk assessments and applicable test scripts in accordance with GxP (GMP) compliance guidelines, 21 CFR Part 11, and validation procedures
• Prepare and review Software Development Life Cycle (SDLC) deliverables, such as validation plans, requirements, specifications, traceability matrices, test protocols (IQ, OQ, PQ), and qualification reports
• Execute and review qualification protocols to ensure compliance with applicable guidelines
• Participate in resolving deviations to protocols and procedures
• Review and revise Standard Operating Procedures (SOPs)
• Communicate CSV approaches and requirements during meetings and workshops
• Develop and deliver client training

Solution Specialist

Computerized Systems Validation Specialist