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Project Manager (CSV remediation)

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Début : ASAP | Durée : Long term | Région : Basel | Budget : ------------ Description : Project Manager Edelway AG is a Professional Services Consultancy based in Switzerland. One of our best clients, a global biopharmaceutical company, based in the Basel area, is currently looking for a Project Manager to join them on a long-term basis. Language: Fluent in English and German. Start Date: ASAP Excellent rate paid per hour. The role: The project manager will be providing guidance, project management and reporting activities related to Computer Systems validation remediation activities. Main Activities: Planning and implementation of qualification/validation activities and projects of existing computer systems. Support and consulting during projects handling GxP critical computer systems. Approving specific computer system validation documentation. Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations. CSV remediation activities to be coordinated in cooperation with a QA CSV lead. Support the IT deliverables for the CSV remediation Your profile: Strong knowledge of the Medical Device industry is required. Experience in leading project teams is required. The person must be analytical, thorough, accurate and proficient in the use of computers Knowledge in MS Project is desired. Background in Quality Systems is required, as the procedures to revise are related directly to the quality of the product or the quality system of the manufacturing. Knowledge of regulation as defined by ISO and FDA is desired. Fluent English and advanced German. If this sounds like your next challenge send me your CV to pmo@edelway.com and I will call you to discuss the role in more details. http://www.edelway.com

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