Assurance Quality Expert H/F

  • Assystem Energy & Infrastructure
  • Suisse
  • sept. 26, 2019
Contrat CDI

Description

Key role: As a consultant, you will support our client to all their industrial project in quality assurance. As an Assurance Quality Expert, your role will be to ensure that the quality of product with the right regulation, such as GMP, client's expectation & MAA application. Key responsibilities - Ensure all quality regulatory & process are implemented, - Monitor quality in all department and ensure compliance with all regulation, • Review and validate all quality documentation with different department, - Monitor Change Control and review operational documentation link to the quality process, - Implementation and ensures adherence of appropriate regulations & quality standards and if needed, suggest improvement, - Provide support to the investigation process and follow-up to assure timely discrepancy closure, - Implementation and ensures adherence of appropriate regulations and quality standards, - Write, review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), specifications, 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. - Advanced technical degree (Master in Quality, in Pharmacist, Industrial Pharmacist...) in Bio- pharma or related fields. - Experience of min. 5 years in the Biopharmaceutical / Life science industry in GMP environments in Quality Management according to FDA, Eudralex vol.4, ICH Q8/Q9/Q10, cGMPsarmacist...) in Bio- pharma or related fields - Extensive experience in quality assurance, with dealing with CAPA, investigation, Change Control - Good knowledge of quality management system - Excellent knowledge of French 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

Key role: As a consultant, you will support our client to all their industrial project in quality assurance. As an Assurance Quality Expert, your role will be to ensure that the quality of product with the right regulation, such as GMP, client's expectation & MAA application. Key responsibilities - Ensure all quality regulatory & process are implemented, - Monitor quality in all department and ensure compliance with all regulation, • Review and validate all quality documentation with different department, - Monitor Change Control and review operational documentation link to the quality process, - Implementation and ensures adherence of appropriate regulations & quality standards and if needed, suggest improvement, - Provide support to the investigation process and follow-up to assure timely discrepancy closure, - Implementation and ensures adherence of appropriate regulations and quality standards, - Write, review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), specifications, 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

- Advanced technical degree (Master in Quality, in Pharmacist, Industrial Pharmacist...) in Bio- pharma or related fields. - Experience of min. 5 years in the Biopharmaceutical / Life science industry in GMP environments in Quality Management according to FDA, Eudralex vol.4, ICH Q8/Q9/Q10, cGMPsarmacist...) in Bio- pharma or related fields - Extensive experience in quality assurance, with dealing with CAPA, investigation, Change Control - Good knowledge of quality management system - Excellent knowledge of French and English

Métier

Contrôle de Réalisation / Qualité

Date de publication

sept. 26, 2019

Secteur

Sciences de la Vie