C&Q Engineer

vor Gesendet 7 Stunden E-Mail Job
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Job Detail

  • Job-ID 326543

Job-Beschreibung

For our client, an international company based in Bern, we are looking for a C&Q Engineer.General Information:Start date: ASAP, latest in January 2025Contract duration: 1 year with possibility of extensionWorkplace: BernWorkload: 100%Home office: possible up to 2 days per weekTasks and Responsibilities:The position will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for Technical Services department in order to ensure that:(re-) qualification of production/QC equipment including thermal mapping studies are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.Commissioning & Qualification Master plans are up to date and established for all ongoing projects.Write/review Commissioning & Qualification plans and reports.Execution of RQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activitiesPlan and track execution of Commissioning & Qualification activities/documentation versus project(s) timelinesPrepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)Coordinate and execute commissioning & qualification activities in collaboration with internal and external partnersCoordination and oversight of external suppliersQualifications and Skills:Bachelor/Master’s degree in technical or natural sciencesWorking experience within pharma/Medical Devices companiesPractical experience in a C&Q role is a mustKnow-how of Qualification requirements according to cGMP regulationsKnow-how of thermal mapping studiesKnow-how of quality assurance principlesExcellent communication skillsAnalytical thinking and problem-solving abilityBusiness fluency in EnglishGerman language is a plusSelf time management

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