Senior Technology Auditor, QA

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Lead, Perform and Report audits • Manage GxP audits • Collect and review responses to audit findings • Act as point of consultancy for Operations and Quality with regards to the implementation of adequate CAPAs • Lead and coordinate internal audit programs • Arrange meetings with client and other key stakeholders as required • Develop and optimize new and existing processes to maintain and improve quality

🎯 Requirements

• Minimum of 4 years experience in quality assurance, auditing, including sound experience of applicable GxP auditing • At least 7 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science • Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research • Ability to rapidly learn, understand and apply applicable Parexel and client procedures • Ability to work flexible and across multicultural environment • Education: Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience

🏖️ Benefits

• Health insurance • Professional development