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Qualification / validation engineer

Le Mont-sur-Lausanne
Agap2 - HIQ Consulting AG
Inserat online seit: 5 Februar
Beschreibung

Since, Agap2Engineer in /, Agap2 is a key player in engineering and consulting present in Switzerland since, we operate through 3 agencies (Basel, Lausanne, Zurich) and support our clients in the management of their on-site projects with our engineers. We are the preferred partner of pharmaceutical industries, biotechnology, medical device manufacturers, and manufacturers in the watchmaking and mechanical sectors. Do you wish to be at the heart of the action? By joining Agap2, you become an expert who supports our clients on their most ambitious projects. Your agility and curiosity are your best assets to immerse yourself in varied work environments, and discovering what lies behind the closed doors of the largest companies is a unique opportunity to develop your expertise and be part of a human and technological adventure. Engineer in / main responsibilities: The specialist in / will be responsible for qualifying production equipment in a pharmaceutical production environment (GMP): Organizing the commissioning activities / / of production equipment in the pharmaceutical industry by organizing appropriate meetings, helping to define requirements and collaborating with other stakeholders (QA, system owners, maintenance/calibration), reviewing and managing the associated workflows for deliverables: introduction forms, URS, protocols, reports, validation plans and summary reports, risk analysis, traceability, GAMP / data integrity. Carrying out tests and/or planning and coordinating interventions of the associated and inquiries, action plans. Support the C&Q department for continuous updates of SOP. Establish regular reports on activities. Desired profile: Engineering degree or Master's degree in a scientific or technical field, at least 3 years of experience in qualifying equipment in a GMP environment, proficiency in French and English, Swiss or EU nationality, or valid Swiss work permit. jid24e3eb8aen jit0206aen jpiy26aen

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