Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!

We are seeking an experienced Computer System Validation (CSV) Specialist to support the validation of computer systems, including environmental monitoring equipment such as particle counters, and ensure compliance with regulatory requirements. The CSV Specialist will be responsible for generating validation deliverables, supporting audits, driving change controls, and assisting in process improvement activities. This role requires in-depth knowledge of cGMP, regulatory standards, and quality systems to ensure robust testing and qualification of systems that are fit for use

Key Responsibilities: Generate and review validation documentation with the site CSV team, ensuring compliance with internal procedures and regulatory standards. Identify opportunities to streamline CSV activities, improving efficiency while maintaining compliance Coordinate and monitor validation phases, providing regular project updates and ensuring timely execution of activities. Create and execute validation test scripts to ensure systems meet cGMP and regulatory requirements. Assist with audits, ensuring compliance and providing support for validated systems during internal and regulatory inspections. Lead change control processes and investigate issues related to validated systems to ensure compliance is maintained. Provide guidance on system upgrades and update operating procedures to meet regulatory requirements Review CSV procedures, provide feedback, and participate in meetings to ensure documentation quality. Engage in the change control process, assessing changes to validated systems for regulatory compliance.