Sr. Auditor

Quality Auditor

The Quality Auditor is responsible for ensuring compliance with regulatory requirements and internal quality standards within a pharmaceutical environment. This role encompasses conducting audits, managing quality systems, and overseeing supplier quality management to ensure that all operations adhere to cGMP, FDA, and other regulatory standards.

Major Responsibilities :

• Conduct Audits : Scheduling, preparing, conducting, and reporting internal and external audits of manufacturing processes, quality systems, and suppliers.
• Evaluate compliance with cGMP, FDA, EU regulations, and internal quality standards.
• Prepare detailed audit reports summarizing findings, non-conformances, and recommendations for improvement.
• Collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs) in response to audit findings and supplier issues.
• Monitor the effectiveness of CAPAs and ensure timely resolution of identified problems.
• Quality System Management : Participate in mock-inspections, as appropriate.
• Drive the escalation of any compliance issues or significant risks identified during audits or when conducting risk assessment.
• Meet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools.
• Supplier Management : Conduct assessments and audits of suppliers to evaluate their compliance with quality standards and regulatory requirements.
• Collaborate with suppliers to develop and implement corrective actions for identified issues.
• Maintain supplier quality metrics and monitor supplier performance to ensure adherence to quality agreements.

Who You Are

Minimum Requirements :

Preferred Qualifications :

What we offer : We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!