Senior Auditor, Quality Assurance

🔥 il y a 12 heures

🇪🇸 Espagne – Télétravail

⏰ Temps Plein

🟠 Senior

🔧 Ingénieur QA

👻 Score fantôme 20%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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ERGOMED

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 1997

💼 Conseil

🏥 Santé

📦 Logistique

Consulting • Healthcare • Logistics

ERGOMED est un groupe international qui fournit des services spécialisés aux industries biotechnologique et pharmaceutique. Il opère à travers plusieurs lignes de services, notamment Ergomed Clinical Research, PrimeVigilance et ADAMAS Consulting, et se consacre à offrir des capacités complètes de CRO (Contract Research Organization). Axé sur l’oncologie, les maladies rares et les essais complexes, il propose également des services de pharmacovigilance et d’information médicale de bout en bout, ainsi que des audits GxP complets. Ergomed s’engage à accompagner le développement de médicaments, avec une présence mondiale dans une centaine de pays environ.

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 within 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 required timelines • Conduct Client PV/QMS system gap analyses and support SOP development • Serve as main QA contact for designated Clients and plan, conduct, and report on Client-requested audits • Attend commercial meetings related to Quality as a Service • Support Clients with mock inspections, training, gap analysis, and procedure drafting/revision • Support audits and inspections performed by Clients, third parties, and regulatory authorities • Develop and train Auditors and other quality employees with Quality leadership • Assist in developing the strategic internal audit program • Maintain current knowledge of international regulatory requirements, guidelines, and best practices • Participate in preparation, authoring, or QC of audit strategies, SOPs, guidelines, and other auditing procedures

🎯 Exigences

• 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 and GCP-related Quality Management and Assurance • Previous 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

🏖️ Avantages

• Remote work option • Collaborative team of experts in clinical research, pharmacovigilance, and quality consulting • Continuous learning and development opportunities • Training and knowledge-sharing opportunities • Diverse and inclusive workplace • Opportunity to make a difference to patients’ lives

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