Sr Specialist QA QC & Release

h3Function Summary /h3 pThe role is responsible for the Quality oversight of Raw Materials and Drug Substance batches release, oversight on all related quality event (e.g. deviations, investigations, CAPA, change control), confirming compliance with GMP, specifications. /p h3Aperçu /h3 pThe role is responsible for the Quality oversight of Raw Materials and Drug Substance batches release, oversight on all related quality event (e.g. deviations, investigations, CAPA, change control), confirming compliance with GMP, specifications. /p pThe role maintains a strong collaboration with other functions (manufacturing, QC, Supply Chain) and Technical SME and promotes continuous improvement and Quality culture. /p pThe tenant of the function ensures product expertise to support investigations and change management. /p h3Duties And Responsabilities /h3 ul liCollect, review and complete all records required for Raw Materials batch review and disposition. /li liCollect, review and complete all records required for Drug Substance batch review, disposition and shipping. /li liAssure QA representative responsibilities in the management of major changes to starting and raw materials, Drug Substance, QC testing, manufacturing process and packaging components. /li liApprove LIMS master data changes /li liWrite, update, and approve quality documentation (SOP, WI, specifications). /li liEnsure QA oversight for all quality events related to the area of responsibility. /li liActively contribute and provide product expertise for major deviations impact assessments and investigation. /li liPromote Quality and compliance initiatives. /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. /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 h3Requirements /h3 ul liAcademic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering). /li liThorough knowledge of cGMP, cGDP and global regulatory requirements applicable to pharmaceutical manufacturing and testing. /li liDemonstrate strong Interpersonal skills and ability to effectively interact with multiple disciplines. /li liStrong verbal and written communication skills with structured communication and presentation ability. /li liCompliance focused whilst assuring a pragmatic and risk-based approach to quality. /li liFluent in English. /li liDemonstrated proficiency in good practice requirements GMP as well as biopharmaceutical industry regulations and standards related to qualification and validation. /li liMust demonstrate proficiencies with the quality systems. /li liThe ability to make pragmatic and compliant decisions. /li liStrong result orientation and committed team member. /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 #J-18808-Ljbffr