GCLP Auditor (Freelance - CAP/CLIA experience required)
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, GCLP, 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. Here your knowledge is valued and shared, not kept in silos. We have built a supportive, collaborative environment where professional growth is encouraged and where you can make a real impact across the industry, working alongside some of the most respected companies in the field.
Requirements
- BSc in Life Science preferred
- Experience in conducting and leading internal and external GCLP audits including CAP/CLIA for a variety of stakeholders
- Experience in conducting a range of service provider audits
- Experience in conducting GCLP systems audits.
- Expert knowledge of national and international GCLP legislation and guidelines
- Ability to conduct remote audits
Nice To Haves
- Experience in coordinating and managing inspection preparation activities for GCLP process inspections both at the sponsor and investigator site.
- Experience in conducting GCLP mock inspections to Competent Authority standard considered a significant advantage.
Responsibilities
- Planning, preparation, conduct, reporting and follow up of various types of GCLP audits including CAP/CLIA according to expected quality and timelines
- Executing audits based on a comprehensive understanding of all regulatory requirements and Good Clinical Laboratory Practice (GCLP).
- Performing GCLP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.
- Coordinating and managing inspection preparation activities for GCLP process inspections both at the sponsor and investigator site.
- Conducting GCLP mock inspections to Competent Authority standard.
Benefits
- Professional growth is encouraged
- Supportive, collaborative environment
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Career Level
Senior
