Azzur Group is a premier GxP compliance and consulting organization committed to delivering high-quality, expertly-backed solutions that drive life science companies towards achieving their goals. We are currently looking for a dedicated and experienced Deviations Investigator to join our dynamic team of problem solvers. The ideal candidate will possess a passion for inquiry and quality, with a keen ability to analyze data and provide actionable insights.
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.
Requirements:
- Bachelor’s degree in Life Sciences, Engineering, or a related field; advanced degree preferred.
- Proven experience in deviation investigation within a regulated environment (pharmaceutical, biotech, or medical device industry).
- Strong understanding of regulatory requirements and compliance standards, including GMP.
- Excellent analytical and problem-solving skills, with the ability to synthesize complex data into clear recommendations.
- Effective communication and interpersonal skills, with the ability to lead discussions and collaborate across teams.
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
