GVP/GCP Auditor, Compliance & Quality Assurance

🔥 2 minutes ago

🌐 Japan, Australia – Remote

🇯🇵 Japan – Remote 🇦🇺 Australia – Remote

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

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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ProPharma

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 2001

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

💰 $8.6M Venture Round on 2020-10

Healthcare • Logistics • Manufacturing

ProPharma is a leading research consulting organization in the life sciences industry. The company specializes in providing custom solutions across the full product lifecycle, from early discovery to post-market monitoring. ProPharma's services include regulatory sciences, clinical research solutions, quality and compliance services, pharmacovigilance, medical information, and R&D technology. Known for its deep domain expertise, ProPharma assists clients in the pharmaceuticals, biotechnology, and medical device sectors with regulatory support, clinical development, and quality management. ProPharma's global team supports a wide range of therapeutic areas including oncology, cardiovascular, and rare diseases, among others, ensuring effective and efficient delivery of life-saving therapies.

📋 Description

• Support management of compliance and quality assurance-related projects • Provide consulting and contract services to clients addressing quality, regulatory, clinical, and safety issues • Execute quality assurance GVP/GCP compliance projects • Conduct audits, QMS development, QA oversight, and regulatory agency action response projects • Support the conduct and promotion of ProPharma Group's CQA program, policies, and strategies • Ensure compliance with GVP/GCP regulations and industry trends • Manage and execute multiple compliance, quality assurance, and Quality and Compliance Consulting services

🎯 Requirements

• Fluency in Japanese and English • Knowledge of applicable PMDA, US FDA, ICH, EMA, and MHRA regulations and guidance documents • Expertise in GVP/GCP systems and ability to provide consultation based on previous experience and system knowledge • Willingness and ability to travel as required • Strong interpersonal and communication skills • Effective written and oral communication skills • Ability to manage and execute multiple compliance, quality assurance, and Quality and Compliance Consulting tasks • Quality orientation and high attention to detail • Strong analytical skills • Bachelor's degree or similar college degree in a scientific discipline as a minimum • Eligibility, as applicable, to be registered as a Qualified Person (QP), Responsible Person (RP), and Responsible Person import (RPi) • Minimum 10 years of relevant experience in quality assurance and regulatory/GxP compliance • Previous registration as a Qualified Person, as applicable • Strong working knowledge of GxP principles and Health Authority regulations • For primarily auditing-focused Consultant, CQA roles: minimum 1 year of experience leading audits and recent auditing experience, with at least 5 audits performed in the past year documented in the candidate's audit log • A graduate degree (MSc/PhD) in a scientific discipline is preferred • Ability to convey information/instructions accurately in English and one other European language preferred (for EU employees)

🏖️ Benefits

• Remote working support • Hybrid working encouraged for new hires near an office • Equal Opportunity Employer workplace committed to diversity, equity, and inclusion