Expert QA QC & Release

ph3Aperçu /h3 h3Function Summary /h3 pThe QA QC Expert is responsible for the quality oversight of Drug Substance batch testing and release, as well as QA oversight for Quality Control (QC) activities at the Incyte Bioplant facility in Yverdon-les-Bains. This includes batch disposition preparation, analytical method transfers/validation, laboratory equipment qualification, and routine testing, ensuring compliance with Incyte Quality policies, cGMP, Swiss, EU, and US FDA regulations. /p h3Key Responsibilities /h3 h3Drug Substance/Product Release /h3 ul liCollect and review all records required for Drug Substance/product batch disposition and shipping. /li liChair weekly Drug Substance/product disposition meetings and maintain related KPIs. /li liReview DS/DP QC data for release. /li liRelease materials including raw materials and QC materials/reagents (e.g., standards, controls). /li liApprove sampling plans. /li /ul h3Quality Control Oversight /h3 ul liManage day-to-day QA oversight of the QC laboratory. /li liQA lead for method transfers and validation, including approval of protocols and reports. /li liQA representative for laboratory SOPs development, updates, and periodic reviews. /li liQA approval of specifications and analytical methods. /li liQA contact for QC deviations, OOS, and OOT as well as for Change controls. /li liReview and approve stability protocols and reports. /li liApprove LIMS master data changes. /li liQA oversight for environmental and utilities monitoring programs, if needed. /li liQA point of contact for Biologic Process Sciences SOPs and equipment commissioning/qualification. /li liSupport commissioning and qualification of laboratory equipment. /li liLead or contribute to risk assessments. /li liCoach QC personnel on quality compliance matters. /li liSupport the preparation of Annual Product Reviews (QC part). /li liEnsure QA oversight for all quality events related to QC activities. /li liContribute to the maintenance of Incyte’s Quality System. /li liSupport Health Authorities’ inspection readiness programs and act as Subject Matter Expert in area of expertise, including the support for submission/filling dossier review. /li liInterpret and implement GMP, regulatory requirements, and Quality Systems regulations applicable to QC. /li liSupport QA team in related support functions including incoming goods and vendor assessments. /li liFoster understanding and application of cGMPs by Bioplant employees. /li liPerform all responsibilities in accordance with company policies, procedures, applicable regulations, and safety requirements. /li liPromote a strong culture of Quality, business integrity, and ethics. /li liAct within compliance and legal requirements as well as company guidelines. /li /ul h3Reporting Line /h3 pDelegation to: Manager Release, QA QC. /p h3Requirements /h3 ul liBachelor’s or academic degree in a relevant field (Chemical Engineering, Bio-engineering, Bioprocessing, Pharmacy, Chemistry, Biotechnology). /li liExpertise in Microbiology and/or Chemical/Biochemical. /li liMinimum 5 years’ experience in a GMP environment. /li liDemonstrated experience in QA for QC topics; experience in batch release preferred. /li liThorough knowledge of biotechnology processes, laboratory equipment, and cGMP/cGDP. /li liFamiliarity with global regulatory requirements applicable to pharmaceutical manufacturing and testing requested. /li liProficiency in quality systems and computerized systems integration. /li liExperience in Health Authorities inspections requested. /li liAbility to make pragmatic and compliant decisions. /li liStrong interpersonal skills and ability to interact effectively across disciplines. /li liStrong result orientation, flexibility, and commitment to teamwork. /li liExcellent written and verbal communication skills in English and French. /li /ul h3Disclaimer /h3 pThe above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. /p h3We Respect Your Privacy /h3 pLearn more at: /p pThe Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. /p pDuring the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. /p pYou may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. /p pYou can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable). /p pPlease contact if you have any questions or concerns or would like to exercise your rights. /p /p #J-18808-Ljbffr