Specialist Compliance DSP

pbOverview /b /brh3SUMMARY /h3 /brpThe compliance specialist is responsible for managing compliance related topics including deviation management, CAPA, risk management, change control, training and batch record review. /p /brpThe compliancespecialist will support cGMP and site quality compliance goals within manufacturing department. He/She will also manage continuous improvements and efficiency projects /p /br /brh3DUTIES AND RESPONSIBILITIES /h3 /brul /brliEnsure that the systems are ready for inspection at all time /li /brliRaise, investigate, assess and close Deviation within timelines /li /brliDefine and plan CAPA to avoid recurrence and allow process improvement. /li /brliDefine and plan effectiveness check /li /brliManage Change Controls Process as compliance resolution or for continuous improvement. /li /brliDefine and maintain KPI for manufacturing support group regarding quality and operational performance /li /brliAct as SME during Heath Authorities inspection by presenting Risk Aassessment, Deviations, Investigations, CCP and CAPAs /li /brliDevelop and maintains business KPI’s and proposes/supports continuous improvements /li /brliAuthor, review and approve SOP/WI or any manufacturing supporting document /li /brliAct as a mentor to DSP manufacturing team members and lead by example to ensure integration of good manufacturing practices /li /brliCoach and train Manufacturing Staff to GMP guidelines and sub-departement specific SOP /li /brliProvide Training Polyvalence Overview within sub-department /li /brliProactively propose problem resolution to process and DSP equipment /li /brliReview and support the review of executed batch report (exception review) /li /brliImplement quality compliance initiatives in the department in collaboration with QA /li /brliCoach and support other team members for quality compliance matters (such as deviation and changes management) /li /brliContribute positively to a strong culture of business integrity and ethics /li /brliAct within compliance and legal requirements as well as within company guidelines /li /brliDelegate to: DSP Manager / Process Support Manager /li /br /ul /br /brh3REQUIREMENTS /h3 /brul /brliBSc, Master or Engineering Degree in Pharma/Biotech engineering /li /brliRelevant experience in biotech industry related to cGMP drug manufacturing and quality. /li /brliDirect experience in FMEA, root cause analysis, and associated quality assessment tools /li /brliTypically minimum 3-5 years of experience /li /brliAbility to work in a fast paced - high regulated environment /li /brliFrench and English (Fluent) /li /brliTeam work oriented mindset /li /br /ul /br /brpDisclaimer: 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 /br /brpWe Respect Your Privacy /p /br /brpLearn more at: /p /br /brpThe 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. During 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 /br /brpYou 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 /br /brpYou 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 /br /brpPlease contact if you have any questions or concerns or would like to exercise your rights. /p /p #J-18808-Ljbffr