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!

Key Responsibilities:

Review validation lifecycle documentation including but not limited to specification documentation (URS, FDS, CS), protocols, reports, executed validation packages, and trace matrices to meet industry standards. Represent the client's best interests and tactfully challenge the robustness of validation documentation. Collaborate with cross-functional teams to implement and maintain validation processes, ensuring alignment with quality assurance principles and best practices. Apply advanced statistical tools and methodologies to analyze validation data, ensuring informed decision-making related to quality outcomes. Provide subject matter expertise during regulatory audits and inspections, ensuring all validation records and documentation are compliant and readily available. Mentor and guide junior validation engineers, fostering a collaborative environment that encourages knowledge sharing and professional growth. Stay abreast of industry best practices, regulatory updates, and emerging trends in quality validation to continuously improve processes.