Quality Assurance Expert H/F

  • Assystem Energy & Infrastructure
  • France
  • déc. 12, 2020
Contrat CDI

Description

As a consultant, you will support our client for all their industrial projects in Quality Assurance. As a Quality Assurance Expert, your role will be to ensure that the product is made according to the right regulation, such as GMP, client's expectations & MAA application. In your daily work, you will be able to: Ensure that all quality regulatory & process are implemented; Monitor the quality in all departments and ensure compliance with all regulations; Monitor Change Control and review operational documentation linked to the quality process; Provide support to the investigation process and follow-up on it to assure timely discrepancy closure: - Write, review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments Specifications (QRAs), Batch Production Documents (BPDs) or Manufacturing Production Documents (MPDs) as needed, - Present systems and provide documentation for self-inspections and external audits, - Implement and ensures adherence of appropriate regulations and quality standards. You have a Master in Quality, in Pharmacy or in related fields; You have an experience of minimum 5 years in the Biopharmaceutical/Life Sciences industries in GMP environments, in Quality Management (according to FDA, Eudralex vol.4, ICH Q8/Q9/Q10, cGMPsarmacist...); You have an extensive experience in Quality Assurance (dealing with CAPA, investigation, Change Control); You have a good knowledge of Quality Management System; You have a good level of French and/or Dutch and English

Description entité

Depuis 50 ans, nous sommes animés par la conviction que les ingénieurs, par leur audace, leur expertise et leur capacité à faire bouger les lignes sont les architectes du monde de demain. Tous les jours, nos 5 700 collaborateurs innovent au contact de leurs clients. Ils accompagnent les plus grands projets de l'ingénierie mondiale dans les domaines de l'énergie, de la santé, des sciences de la vie et des transports. Groupe international en forte croissance, nous sommes présents dans 14 pays (Europe, Moyen-Orient, Asie, Afrique). Acteur reconnu pour notre expertise en CQV (Commissioning Qualification Validation) et experts des projets à fortes contraintes techniques et réglementaires, nous accompagnons les laboratoires pharmaceutiques et industries de pointe dans leurs investissements et leurs enjeux liés à la sécurité et à la diminution des coûts et des délais de mise sur le marché. Pour nos clients, nous innovons et intégrons des technologies disruptives dans les domaines de l'intégrité des données, la cybersécurité et la maintenance prédictive.

Entité

Assystem Care

Mission

As a consultant, you will support our client for all their industrial projects in Quality Assurance. As a Quality Assurance Expert, your role will be to ensure that the product is made according to the right regulation, such as GMP, client's expectations & MAA application. In your daily work, you will be able to: Ensure that all quality regulatory & process are implemented; Monitor the quality in all departments and ensure compliance with all regulations; Monitor Change Control and review operational documentation linked to the quality process; Provide support to the investigation process and follow-up on it to assure timely discrepancy closure: - Write, review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments Specifications (QRAs), Batch Production Documents (BPDs) or Manufacturing Production Documents (MPDs) as needed, - Present systems and provide documentation for self-inspections and external audits, - Implement and ensures adherence of appropriate regulations and quality standards.

Profil

You have a Master in Quality, in Pharmacy or in related fields; You have an experience of minimum 5 years in the Biopharmaceutical/Life Sciences industries in GMP environments, in Quality Management (according to FDA, Eudralex vol.4, ICH Q8/Q9/Q10, cGMPsarmacist...); You have an extensive experience in Quality Assurance (dealing with CAPA, investigation, Change Control); You have a good knowledge of Quality Management System; You have a good level of French and/or Dutch and English

Métier

Contrôle de Réalisation / Qualité

Date de publication

déc. 12, 2020

Secteur

Sciences de la Vie