GMP Auditor (Freelance)

Adamas Consulting • Raleigh, NC

11d • Hybrid

About The Position

ADAMAS Consulting helps the world's pharmaceutical and biotechnology companies uphold the highest standards of quality, compliance and patient safety. Since 2007 we have partnered with organizations across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is intelligence: helping clients see the compliance risks that matter most and prevent the problems that could put patients at risk. That takes sharp, independent thinking and deep expertise, which is exactly what our people bring.

Requirements

• Experience in conducting and leading internal and external GMP audits for a variety of stakeholders
• Experience and full understanding of current applicable regulatory standards.
• Expert knowledge of national and international GMP legislation and guidelines
• Proficient in managing projects and ensuring deliverables are provided in a timely manner
• Ability to identify issues and offer solutions in a pragmatic way

Nice To Haves

• Experience in conducting a range of service provider audits would be an advantage (e.g., API manufacturers, CMOs)
• Experience in coordinating and managing inspection preparation activities for GMP process inspections both at the sponsor and investigator site.
• BS in Life Science preferred

Responsibilities

• Planning, preparation, conduct, reporting and follow up of various types of GMP audits according to expected quality and timelines
• Executing audits based on a comprehensive understanding of all regulatory requirements and Good Manufacturing Practice (GMP)
• Performing GMP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.

What This Job Offers

• Career Level: Senior