QA Senior engineer tech transfer & process validation H/F

  • Assystem Energy & Infrastructure
  • Lausanne, Suisse
  • oct. 06, 2020
Contrat CDI

Description

Define the technology transfer strategy Support the technology transfers and process validation  to the new biotech production site Support the implementations and performance of Quality operations (new process introduction, electronic batch records, change controls, quality events, periodic reviews, change-over management and others) Act within compliance and legal requirements as well as within company guidelines Work with the project team and the engineering companies on the detailed design deliverables concerning process equipment requirements and actively support the risk assessment exercises (FMECA) Review and approve process equipment related documentation (procedures, layouts, FAT/SAT protocols and reports, qualification protocols and reports, CAPAs, deviations and change controls) to ensure compliance with cGMP and applicable regulations Support the Commissioning & Qualification activities during FAT at supplier’s and on site in close collaboration with manufacturing and engineering teams Create SOPs for process equipment qualification / validation and subsequent operations Conduct suppliers’audits as well as self-inspections At all times work in view of the site readiness for regulatory inspections (Swissmedic and International) Master’s Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing Must have minimum of 7 years in a Quality Assurance role in a biopharmaceutical manufacturing environment Strong experience in Quality Assurance for biopharmaceutical validation, technology transfers and manufacturing. Strong knowledge of biotechnological technologies, processes, with a demonstrated experience in Technology Transfers and process validation Demonstrated proficiency in good practice requirements GMP as well as biopharmaceutical industry regulations and standards related to qualification and validation Must have proficiencies with the quality systems and, preferably, with business processes associated with automation and integration of testing and production systems Experience in health authorities inspections The ability to make pragmatic and compliant decisions Strong result orientation and committed team member Excellent knowledge of French and English Excellent written and verbal communication skills

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

Define the technology transfer strategy Support the technology transfers and process validation  to the new biotech production site Support the implementations and performance of Quality operations (new process introduction, electronic batch records, change controls, quality events, periodic reviews, change-over management and others) Act within compliance and legal requirements as well as within company guidelines Work with the project team and the engineering companies on the detailed design deliverables concerning process equipment requirements and actively support the risk assessment exercises (FMECA) Review and approve process equipment related documentation (procedures, layouts, FAT/SAT protocols and reports, qualification protocols and reports, CAPAs, deviations and change controls) to ensure compliance with cGMP and applicable regulations Support the Commissioning & Qualification activities during FAT at supplier’s and on site in close collaboration with manufacturing and engineering teams Create SOPs for process equipment qualification / validation and subsequent operations Conduct suppliers’audits as well as self-inspections At all times work in view of the site readiness for regulatory inspections (Swissmedic and International)

Profil

Master’s Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing Must have minimum of 7 years in a Quality Assurance role in a biopharmaceutical manufacturing environment Strong experience in Quality Assurance for biopharmaceutical validation, technology transfers and manufacturing. Strong knowledge of biotechnological technologies, processes, with a demonstrated experience in Technology Transfers and process validation Demonstrated proficiency in good practice requirements GMP as well as biopharmaceutical industry regulations and standards related to qualification and validation Must have proficiencies with the quality systems and, preferably, with business processes associated with automation and integration of testing and production systems Experience in health authorities inspections The ability to make pragmatic and compliant decisions Strong result orientation and committed team member Excellent knowledge of French and English Excellent written and verbal communication skills

Métier

Support & Contrôle Projet

Date de publication

oct. 06, 2020

Secteur

Sciences de la Vie