GMP Auditor – Freelance

Job not on LinkedIn

🔥 0 minutes ago

🇳🇿 New Zealand – 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 GMP audits according to expected quality and timelines • Execute audits based on a comprehensive understanding of regulatory requirements and Good Manufacturing Practice (GMP) • Perform GMP quality assurance projects on behalf of pharmaceutical and biotechnology client companies • Coordinate and manage inspection preparation activities for GMP process inspections at sponsor and investigator sites • Manage projects and ensure deliverables are provided in a timely manner • Identify issues and offer pragmatic solutions

🎯 Requirements

• Experience in conducting and leading internal and external GMP audits for a variety of stakeholders • Experience in conducting a range of service provider audits would be an advantage (e.g., API manufacturers, CMOs) • Experience in coordinating and managing inspection preparation activities for GMP process inspections at sponsor and investigator sites • Experience and full understanding of current applicable regulatory standards • Expert knowledge of national and international GMP legislation and guidelines • Proficient in managing projects and ensuring deliverables are provided in a timely manner • Ability to identify issues and offer solutions in a pragmatic way • BS in Life Science preferred • Ability to travel up to 40% • Ability to conduct remote audits

🏖️ Benefits

• Up to 40% travel • Ability to conduct remote audits • Collaborative team environment • Opportunity to contribute to safe and effective pharmaceutical treatment • Work with experts in clinical research, pharmacovigilance, and quality consulting