Specialist Quality System

h3Overview /h3 h3SUMMARY /h3 pWith a reporting line in the Quality Assurance team, this position supports the Quality System activities and related operations associated with the maintenance of a Quality Management System for our large scale API bio-manufacturing facility. Responsibilities include supporting the management and maintenance of Quality Management Systems according to quality policies, cGMP, Swiss, EU / US FDA Regulations. More specifically this position will participate to the improvement, maintenance and application of the following QA processes: Training, Documentation (including controlled copy logbook management), GXP Personnel management, Retention/Archiving, deviation Change control. /p h3Duties And Responsabilities /h3 ulliAct as a QA Admin and SME on eDMS and eQMS including Documentation, Retention/Archiving, Training, deviation change control processes /liliTrain users on documentation Management and Training systems, and support other training where necessary /liliSupport actively system users in their daily tasks within the different quality systems /liliAct as key contact point for users at the Bioplant for specific troubleshooting. Escalate unresolved topics to Global QMS team when necessary /liliManage the documentation change control process and Release Bioplant documentation and associated training /liliMaintain local training matrix and assign training within the e-DMS /liliSupport Bioplant departments in the training strategy definition and maintenance /liliResponsible for local GMP documents filing and archiving system /liliArchive department paper document internally and be the point of contact for external archiving /liliIssue / reconciled controlled copies monitor them with department /liliEnsure employees onboarding on the different Quality Systems, Welcome Day and delivery-related training /liliMaintain employee’s initials and personnel onboarding/termination up to date /liliDevelop training materials deliver QMS training to users regarding the different Quality Systems (including but not limited to: Good documentation practices, cGMP, Document owner or viewer within the eDMS, etc...) /liliDrive continuous improvement of all QS processes /liliPrepare and maintain site Dashboards /liliPrepare KPIs extract and metrics follow-up to monitor Quality systems health and compliance with cGMP and internal applicable documents (including QMR metrics) /liliParticipate to internal audits /liliAct as QA approver or SME when necessary on changes, deviation, CAPA /liliParticipate, and lead when identified, QA Systems improvements projects /liliParticipate to inspection preparation, logistic and presentation /liliAt all times work in view of the site readiness for regulatory inspections (Swissmedic and International) /liliContribute positively to a strong culture of business integrity and ethics /liliAct within compliance and legal requirements as well as within company guidelines /li /ul pDelegate to QA Specialist , QA Manager /p h3Requirements /h3 ulliMust speak, read write in both English and French /liliMust have 2 year of experience in a GMP environment including the use of e-systems (Biotech, pharmaceutical or equivalent industries) /liliGood understanding of basic GMP requirements related to Quality system activities (biopharmaceutical industry regulations and standards with Quality Systems) is a plus /liliGood Knowledge on quality system software (Veeva is a plus) /liliExperience in health authorities inspections is a plus /liliAbility to make pragmatic and compliant decisions /liliStrong result orientation and committed team member /liliExcellent written and verbal communication skills /li /ul h3Education /h3 ulliBachelor's Degree in relevant field such as Pharmacy, Chemistry, Biology or Bio-engineering, Bioprocessing is a plus /liliTrainer and/or auditor certification is a plus /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