Senior Auditor, Quality Assurance – Pharmacovigilance Audit/GCP Audit

🔥 6 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 19%

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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

• Manage and conduct internal and contracted audits for the Company and its Clients • Provide input into audit strategy and risk-based audit planning • Lead process and complex audits • Provide QA consultancy activities within the area of GxP expertise • Conduct audits of Company partners, vendors, service providers, internal systems, study files, investigational sites, and third parties on behalf of Clients • Manage pre-audit activities effectively • Review and approve final CAPA plans from contracted audits within mandated timelines • Conduct Client PV/QMS system gap analyses and support SOP development • Act as the main QA contact for designated Clients • Plan, conduct, and report on audits requested by Clients • Attend commercial meetings related to Quality as a Service • Support Quality as a Service activities, including mock inspections, training, gap analysis, and procedure drafting and revision • Support audits and inspections performed by Clients, third parties, and regulatory authorities • Work with Quality leadership to develop and train Auditors and other quality employees • Assist in developing the strategic internal audit program • Maintain current knowledge of international regulatory requirements, guidelines, and best practices • Participate in knowledge-sharing and continuous learning and development • Participate in authoring or quality control of audit strategies, SOPs, guidelines, and other documented procedures

🎯 Requirements

• Bachelor’s degree in a scientific discipline required; Master’s degree preferred, or equivalent relevant industry experience • Strong previous pharmaceutical and/or biotech pharmacovigilance experience • Strong understanding of GVP & GCP related Quality Management and Assurance • Previous experience of GVP and GCP auditing experience in an Audit Lead role • Analytical, written and oral communication skills • Ability to manage assigned tasks and deliver expected deliverables in an organized and timely manner • Ability to proactively communicate changes in pre-established goals and deadlines • Ability to think strategically and work collaboratively using risk-based, proactive approaches to problem-solving • Strong team player • Fluent in English, written and spoken • Additional/local languages are a plus but not required

🏖️ Benefits

• Passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting • Diverse and inclusive workplace where every voice counts • Opportunities for continuous learning and development • Knowledge-sharing and learning opportunities • Opportunity to make a difference by helping bring safe and effective pharmaceutical treatment to patients around the world

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