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!

Essential Duties and Responsibilities:

Responsible for writing investigations, deviations, CAPAs and Change Controls with client input. Develops Validation Plans for small to medium size validation projects, qualification of equipment, facilities, utilities, as well as cleaning sterilization, and manufacturing process validation. Performs on site or support work for a client under minimal supervision. Validation protocol execution for FAT/SAT/IQ/OQ/PQ, thermal mapping of temperature controlled chambers, warehouses, and sterilization processes. Initiates and performs investigations to close out deviations. Ensures corrective actions are resolved in a timely manner. Supports the resolution of regulatory observations or manufacturing site issues. Performs such onsite activities as P&ID Walkdowns and PPQ Provides assistance with project management for commissioning, qualification of new engineering systems.