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The auditor will plan, prepare, conduct, and report on GCLP audits, including CAP CLIA, while ensuring compliance with regulatory requirements. They will also perform quality assurance projects and manage inspection preparation activities for both sponsors and investigator sites.
Candidates should have a BSc in Life Science and extensive experience in leading internal and external GCLP audits. Expert knowledge of national and international GCLP legislation and guidelines is required.
Medicine moves forward here. So will you.
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.
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.
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.
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
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.
PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative clinical safety and PV services for pharmaceutical, biotechnology and medical device companies. Our leaders have an unrivalled reputation in the sector with a network of SMEs across the world. These include former senior regulators and consultants with expansive industry experience.
Offices: The Surrrey Research Park, 1 Occam Court, Guildford, Surrey GU2 7HJ, GB · Oreškovićeva ul. 6H, Zagreb, 10 020, HR · Đorđa Stanojevića 14, Novi Beograd, 11 070, RS · Herriotstr. 1,, Frankfurt am Main, Frankfurt 60528, DE · Václavské náměstí 2132/47, Flow Building, Prague, Prague 1 110 00, CZ
