StellenbeschreibungppPerkinElmer's OneSource team is looking for a bValidation Compliance Engineer /b to join our team in Schachen, Switzerland. In this role You'll review and approve documentation for calibration, maintenance, and repair activities, release assets for use, and manage changes, deviations, and CAPAs—working closely with Calibration Maintenance Engineers to keep everything GxP-compliant. /p pMore information about our OneSource services: OneSource Laboratory Solutions | PerkinElmer /p h3Document Review Approval / Asset Release /h3 ul liReviews and approves documents as part of calibration, maintenance, and repair work /li liCollaborate closely with internal and external Calibration Maintenance Engineers, to close eventual GDP gaps in provided documentation /li liReleases assets after successful completion of calibration, maintenance, and repair work /li liProcesses Changes, Temporary Changes, Deviations, and CAPA related with calibration and maintenance /li liContributes to changes and investigations as a member of cross-functional teams /li /ul h3Data Management / Administrative Release /h3 ul liAdds, updates, reviews, and releases positions in the Customer calibration/maintenance databases (CCMS/CMMS) /li liReviews, approves, and performs administrative release of successful calibration and maintenance entries in Customer CCMS/CMMS systems /li /ul h3Requirements /h3 ul liBachelor’s degree in Life Sciences or Quality/Compliance discipline or equivalent experience preferred. /li liMinimum of five (5) years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles /li liKnowledge of cGMP, Annex 1 and validation regulations and requirements. /li liKnowledge of GMP, GLP, GDP, pharmacopeia and regulatory requirements preferred. /li liDeveloped Customer service mindset /li liBe passionate about detail and tech aspects /li liStrong written and verbal communication skills. /li liAbility to work both independently and as a team member, within prescribed guidelines, coping with frequent grey areas / uncertainty. /li /ul h3Join our Team! /h3 pWe are strongly committed to the development of your career and giving you opportunities to learn and grow. We make a difference for you while you make a difference in the world! /p /p #J-18808-Ljbffr
