QA Senior engineer tech transfer & process validation H/F
Assystem Energy & Infrastructure
Lausanne, Suisse
vor 3 Tg.

Description

Define the technology transfer strategySupport the technology transfers and process validation to the new biotech production siteSupport 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 guidelinesWork 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 regulationsSupport the Commissioning & Qualification activities during FAT at supplier’s and on site in close collaboration with manufacturing and engineering teamsCreate SOPs for process equipment qualification / validation and subsequent operationsConduct suppliers’audits as well as self-inspectionsAt 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, BioprocessingMust have minimum of 7 years in a Quality Assurance role in a biopharmaceutical manufacturing environmentStrong 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 validationDemonstrated proficiency in good practice requirements GMP as well as biopharmaceutical industry regulations and standards related to qualification and validationMust have proficiencies with the quality systems and, preferably, with business processes associated with automation and integration of testing and production systemsExperience in health authorities inspectionsThe ability to make pragmatic and compliant decisionsStrong result orientation and committed team memberExcellent knowledge of French and EnglishExcellent 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.

Mission

Define the technology transfer strategySupport the technology transfers and process validation to the new biotech production siteSupport 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 guidelinesWork 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 regulationsSupport the Commissioning & Qualification activities during FAT at supplier’s and on site in close collaboration with manufacturing and engineering teamsCreate SOPs for process equipment qualification / validation and subsequent operationsConduct suppliers’audits as well as self-inspectionsAt 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, BioprocessingMust have minimum of 7 years in a Quality Assurance role in a biopharmaceutical manufacturing environmentStrong 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 validationDemonstrated proficiency in good practice requirements GMP as well as biopharmaceutical industry regulations and standards related to qualification and validationMust have proficiencies with the quality systems and, preferably, with business processes associated with automation and integration of testing and production systemsExperience in health authorities inspectionsThe ability to make pragmatic and compliant decisionsStrong result orientation and committed team memberExcellent knowledge of French and EnglishExcellent written and verbal communication skills

Métier

Support & Contrôle Projet

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