Specialist QC Stability and Raw Materials

ph3Overview /h3 pJob Summary (Primary function) /p pThe QC Specialist Stability and Raw Materials is responsible for the operational activities related to Stability testing and Raw Materials (RM) testing release at Incyte QC Bioplant. /p pThis includes (but is not limited to) the planification, the definition of the analyses to be carried out, the samples shipment for outsourced testing, the execution of analytical testing upon request, the internal external results/data review and their approval within the defined lead time. /p pThe QC Specialist QC Specialist Stability and Raw Materials is the point of contact for Quality Assurance, Manufacturing, Supply Chain, Warehouse, other Quality Control teams and External Laboratories. /p pThe QC Specialist QC Specialist Stability and Raw Materials owns the deviations, CAPA and change controls for the QC activities under his/her responsibilities. /p pEssential Functions of the Job (Key responsibilities) /p ul liPlan and coordinate Raw Materials (RM) lab activities of the team of technicians. /li liCoordinate the design, initiation, and execution of stability studies according to ICH and regulatory requirements. /li liCollaborate with QC analysts and laboratory supervisors to ensure timely completion of testing /li liAct as the primary point of contact for stability-related queries across QC, QA, Manufacturing, Regulatory Affairs, and Supply Chain. /li liSupport regulatory submissions by providing stability data and summaries. /li liParticipate in cross-functional meetings to provide updates on ongoing stability studies and timelines /li liAccountable for the on-time execution of stability programs. Accountable for Stability reporting, /li liExecute data review for Stability and RM for internal and external testing. /li liAuthor, review, and maintain Standard Operating Procedures, Work Instructions, and all other quality documents related to areas of responsibility, as well as support other areas as required. /li liDefine the appropriate test of RM specifications in compliance with reference documents (USP, Eur. Ph., JP, BLA, and beyond) /li liContribute to the introduction of new products at BioPlant: be the point of contact and manage the interface between Analytical Transfer Validation and QC Microbiology team /li liEnsure efficient communication between Quality Assurance, Manufacturing, Supply Chain, Warehouse, Quality Control teams and External Laboratories /li liContribute to health authority inspections, internal and corporate audits, response to observations. /li liOwn and lead quality events management (deviations, investigations, CAPA, change control...) /li liContribute positively to a strong culture of quality, integrity and ethics in business. /li liAct in accordance with legal and compliance requirements and company guidelines /li liOther activities upon request. /li liDelegation to the Manager of QC Lab Operations. /li /ul pQualifications (Minimal acceptable level of education, work experience, and competency) /p ul liBachelor with 5 years or CFC / BTS (in Physico-chemistry, Biotechnology) with at least 10 years of experience in a laboratory environment. /li liStrong experience in a GMP environment, in a pharmaceutical or biotechnology company /li liDeep knowledge of Analytical testing and Pharmacopoeias /li liAbility to work in a highly regulated and fast-changing environment /li liHighly developed team spirit /li liProactivity and pragmatism /liliRigorous and organized /li liBe able to make proposals /li liHave a spirit of synthesis /li liLanguage: French (fluent) and English (advanced; C1) /li /ul pDisclaimer: The 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 pWe Respect Your Privacy /p 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