Expert Compliance Manufacturing

ph3Overview /h3 pThe Compliance Training Expert is responsible for managing compliance related topics including deviation management, CAPA, risk management, change control and training. /p pHe/She will coordinate with Manufacturing Manager complete adherence to GMP rules, training process of the whole MFG staff. During routine manufacturing operation, he/she supports operational activities, continuous improvement and compliance. /p h3DUTIES AND RESPONSIBILITIES /h3 ul liEnsure that the systems are ready for inspection at all time /li liRaise, investigate, assess and close Deviation within timelines /li liDefine and plan CAPA to avoid recurrence and allow process improvement. /li liDefine and plan effectiveness check /li liManage Change Controls Process as compliance resolution or for continuous improvement. /li liDefine and maintain KPI for manufacturing support group regarding quality and operational performance /li liAct as SME during Heath Authorities inspection by presenting Risk Aassessment, Deviations, Investigations, CCP and CAPAs /li liDevelop and maintains business KPI’s and proposes/supports continuous improvements /li liAuthor, review and approve SOP/WI or any manufacturing supporting document /li liAct as a mentor to manufacturing team members and lead by example to ensure integration of good manufacturing practices /li liMaintain an adequate Training Process and warranty a full adherence within MFG staff /li liCoach and train Manufacturing Staff to GMP guidelines and sub-departement specific SOP /li liProvide Training Polyvalence Overview within sub-department /li liProactively propose problem resolution to process and equipment /li liImplement quality compliance initiatives in the department in collaboration with QA /li liCoach and support other team members for quality compliance matters (such as deviation and changes management) /li liContribute positively to a strong culture of business integrity and ethics /li liAct within compliance and legal requirements as well as within company guidelines /li liDelegate to: Process Support Manager /li /ul h3REQUIREMENTS /h3 ul liBSc, Master or Engineering Degree in Pharma/Biotech engineering /li liRelevant experience in biotech industry related to cGMP drug manufacturing, process design, equipment qualification, change control, equipment modification, and process validation /li liDirect experience in FMEA, root cause analysis, and associated quality assessment tools /li liTypically minimum 5-7 years of experience /li liProven leadership experience managing a team /li liAbility to work in a fast paced – high regulated environment /li liFrench and English (Fluent) /li liTeam work oriented mindset /li liAct within compliance and legal requirements as well as within company guidelines /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