GCP AUDITOR (FREELANCE)

<ul><li><p>Planning, preparation, conduct, reporting and follow up of various types of GCP audits according to expected quality and timelines&#xa0;&#xa0;</p></li><li><p>Executing audits based on a comprehensive understanding of all regulatory requirements and Good Clinical Practice (GCP). &#xa0;</p></li><li><p>Performing GCP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry. &#xa0;&#xa0;</p></li></ul> <ul><li><p>BSc in Life Science preferred &#xa0;</p></li><li><p>Experience in conducting and leading internal and external GCP audits for a variety of stakeholders &#xa0;</p></li><li><p>Experience in conducting a range of service provider audits (e.g., full-service CRO, biostatistics, data management, phase I) &#xa0;</p></li></ul><ul><li><p>Experience in conducting GCP systems audits. &#xa0;</p></li><li><p>Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site. &#xa0;</p></li><li><p>Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage. &#xa0;</p></li><li><p>Expert knowledge of national and international GCP legislation and guidelines &#xa0;</p></li><li><p>Up to 40% travel and ability to conduct remote audits&#xa0;</p></li></ul> <p>Why ADAMAS?    &#xa0;</p><p>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.&#xa0;&#xa0;</p><p>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.&#xa0;</p><ul><li><p>Quality: we hold ourselves to the standard patients deserve.&#xa0;</p></li></ul><ul><li><p>Integrity and trust: we do the right thing, especially when it is hard.&#xa0;</p></li></ul><ul><li><p>Drive and passion: we care about the outcome, because someone is waiting on it.&#xa0;</p></li></ul><ul><li><p>Agility and responsiveness: we move quickly, because patients cannot wait.&#xa0;</p></li></ul><ul><li><p>Belonging: everyone is welcome, and every voice counts.&#xa0;</p></li></ul><ul><li><p>Collaborative partnerships: we go further by going together.&#xa0;</p></li></ul><p>We look forward to welcoming your application.&#xa0;</p>