QA support Lab Support H/F

  • Assystem Energy & Infrastructure
  • Lausanne, Suisse
  • janv. 28, 2021
Contrat CDI

Description

As a consultant, you will support the qualification and validation commissioning and qualification of labs equipments Key responsibilities : Act as the main point of contact for all quality compliance key topics regarding labs equipments Review and approve the URS and relevant documentation and support actively the risk assessment exercises (FMECA) Support the Commissioning & Qualification activities Support the creation of procedures, protocols and reports for qualification / validation Ensure qualification and validation of labs equipments Act within compliance and legal requirements as well as within company guidelines Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by bioplant employees 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, cGMPs Extensive experience in quality assurance, with dealing with CAPA, investigation, Change Control Good knowledge of quality management system Excellent knowledge of French and English Well organized and independent in daily task with a good team spirit Ability to cope in very fast-moving environment Be proactive, and suggest improvement with impact and effect

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 the qualification and validation commissioning and qualification of labs equipments Key responsibilities : Act as the main point of contact for all quality compliance key topics regarding labs equipments Review and approve the URS and relevant documentation and support actively the risk assessment exercises (FMECA) Support the Commissioning & Qualification activities Support the creation of procedures, protocols and reports for qualification / validation Ensure qualification and validation of labs equipments Act within compliance and legal requirements as well as within company guidelines Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by bioplant employees 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, cGMPs Extensive experience in quality assurance, with dealing with CAPA, investigation, Change Control Good knowledge of quality management system Excellent knowledge of French and English Well organized and independent in daily task with a good team spirit Ability to cope in very fast-moving environment Be proactive, and suggest improvement with impact and effect

Métier

Montage / Essais / Exploitation / Maintenance

Date de publication

janv. 28, 2021

Secteur

Sciences de la Vie