GCLP Auditor - Freelance, CAP/CLIA experience required

Job Description

• 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.   

Qualifications

• 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.  

• 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.  

• Expert knowledge of national and international GCLP legislation and guidelines  

• Up to 40% travel and ability to conduct remote audits 

Additional Information

Why ADAMAS?     

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.  

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here. 

• Quality: we hold ourselves to the standard patients deserve. 

• Integrity and trust: we do the right thing, especially when it is hard. 

• Drive and passion: we care about the outcome, because someone is waiting on it. 

• Agility and responsiveness: we move quickly, because patients cannot wait. 

• Belonging: everyone is welcome, and every voice counts. 

• Collaborative partnerships: we go further by going together. 

We look forward to welcoming your application.