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!
Position Overview: As a Deviations Investigator, you will be responsible for leading the investigation of deviations within various processes at our client facilities. Your role will involve collaborating with cross-functional teams, facilitating the identification of root causes, and advising on corrective actions to prevent recurrence, ensuring adherence to regulatory standards.
Key Responsibilities:
Conduct thorough investigations of deviations from established processes and protocols. Lead root cause analyses and assess potential impacts on product quality and compliance. Collaborate with Quality Assurance and Quality Control teams to ensure investigations are conducted promptly and comprehensively. Prepare detailed investigation reports documenting findings, conclusions, and recommendations for corrective actions. Facilitate team discussions and presentations to drive consensus on investigations and resultant actions. Ensure compliance with regulatory requirements and Azzur policies throughout the investigation process. Participate in CAPA investigations relating to deviations and support the development of subsequent corrective actions. Provide training and guidance to junior staff or clients on investigation processes and methodologies.