CQV Cleaning Consultant

As a CQV Cleaning Consultant at Azzur Group, your key responsibilities will include developing and executing commissioning, qualification, and validation protocols for various GMP systems. This encompasses fill lines, compressed air systems, and clean utilities. You will also be expected to perform risk and impact assessments, lead deviation investigations, and ensure compliance with FDA and cGMP guidelines, making your role crucial in maintaining high operational standards.

To qualify for the CQV Cleaning Consultant position at Azzur Group, candidates should possess a Bachelor's degree in Engineering—like Mechanical, Chemical, or Biomedical—and have 8-10 years of relevant experience in the pharmaceutical, biotech, or medical device industries. A strong understanding of GMP environments and FDA regulations, along with hands-on experience in aseptic manufacturing, is highly preferred.

Azzur Group actively promotes a diverse culture within the workplace, believing that diversity enhances talent, innovation, and creativity. As a CQV Cleaning Consultant, you will be part of an inclusive environment that values varied perspectives, allowing you to flourish and contribute effectively to our goals.

At Azzur Group, a CQV Cleaning Consultant can look forward to a comprehensive benefits package. This includes health care plans covering medical, dental, and vision, a retirement plan with 401k options, and life insurance programs. These benefits underscore our commitment to supporting the health and well-being of our valuable team members.

The work environment for a CQV Cleaning Consultant at Azzur Group is collaborative and dynamic. You will engage with various teams across Engineering, QA, Manufacturing, and Facilities, ensuring that quality and compliance are maintained. This role involves a blend of independent work and teamwork, all within a fast-paced, project-based setting that values innovation and quality.

In preparing for this question, consider discussing challenges such as ensuring compliance with regulatory standards, managing multiple projects simultaneously, and maintaining effective communication among cross-functional teams. Explain how your experience has equipped you to handle these challenges by leveraging past successes or strategies.

Express your commitment to ongoing education by mentioning resources such as attending industry conferences, subscribing to relevant publications, or participating in professional organizations. Also, emphasize your proactive approach to integrating new regulatory knowledge into your work processes.

In your response, detail the specific types of validation protocols you've developed or executed, such as IQ, OQ, or PQ. Provide examples that highlight your knowledge of GMP systems and how your contributions ensured successful compliance and operational quality.

Discuss your methodologies for conducting risk assessments, including key factors you evaluate and how you document your findings. Highlight any specific instances where your risk assessment led to improved compliance or operational efficiencies, demonstrating your proactive approach.

Share a specific example that showcases your role and contributions within a cross-functional team. Highlight how your collaboration led to achieving common objectives, particularly in terms of CQV processes or quality compliance, emphasizing your communication and problem-solving skills.

Discuss your organizational and time management strategies, including techniques like prioritization, setting deadlines, and utilizing task management tools. Mention how these strategies have successfully helped you navigate busy schedules while maintaining high-quality work.

Present this as an opportunity to discuss your critical thinking and problem-solving skills. Detail the nature of the deviation, your analysis process, and the corrective and preventive actions you implemented, clearly demonstrating your methodology for ensuring compliance.

Describe your audit preparation process, emphasizing your organizational skills, attention to detail, and familiarity with regulatory expectations. Provide examples from your past experience that highlight your contributions to successful audits.

Outline your experience with clean utility systems, including specifics such as WFI and clean steam. Describe the validation steps you've taken and any challenges faced, illustrating your thorough understanding of CQV in cleanroom environments.

Emphasize your meticulous attention to detail in validation documentation. Discuss best practices you follow to ensure compliance, like regular reviews, peer evaluations, and understanding of electronic quality systems, showcasing your commitment to high standards in documentation.