GCP Auditor – Freelance

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🔥 0 minutes ago

🌐 New Zealand, Australia – Remote

🇳🇿 New Zealand – Remote 🇦🇺 Australia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔎 Auditor

👻 Ghost score 16%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Plan, prepare, conduct, report, and follow up on various types of GCP audits according to expected quality and timelines • Execute audits based on comprehensive understanding of regulatory requirements and Good Clinical Practice (GCP) • Perform GCP quality assurance projects for pharmaceutical and biotechnology client companies • Coordinate and manage inspection preparation activities for GCP process inspections at sponsor and investigator sites • Conduct GCP mock inspections to Competent Authority standard

🎯 Requirements

• Experience in conducting and leading internal and external GCP audits for a variety of stakeholders • Experience conducting service provider audits, including full-service CRO, biostatistics, data management, and phase I audits • Experience conducting GCP systems audits • Experience coordinating and managing inspection preparation activities for GCP process inspections at sponsor and investigator sites • Expert knowledge of national and international GCP legislation and guidelines • Ability to travel up to 40% • Ability to conduct remote audits • BSc in Life Science preferred • Experience conducting GCP mock inspections to Competent Authority standard is a significant advantage

🏖️ Benefits

• Up to 40% travel • Supportive, collaborative environment • Professional growth encouraged • Opportunity to make a real impact across the pharmaceutical and biotechnology industry • Passionate and collaborative team of experts • Diverse and inclusive workplace where every voice counts • Collaborative partnerships