Specialist Quality System

ph3Overview /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 RESPONSIBILITIES /h3 ul liAct as a QA Admin and SME on eDMS and eQMS including Documentation, Retention/Archiving, Training, deviation change control processes /li liTrain users on documentation Management and Training systems, and support other training where necessary /li liSupport actively system users in their daily tasks within the different quality systems /li liAct as key contact point for users at the Bioplant for specific troubleshooting. Escalate unresolved topics to Global QMS team when necessary /li liManage the documentation change control process and Release Bioplant documentation and associated training /li liMaintain local training matrix and assign training within the e-DMS /li liSupport Bioplant departments in the training strategy definition and maintenance /li liResponsible for local GMP documents filing and archiving system /li liArchive department paper document internally and be the point of contact for external archiving /li liIssue / reconciled controlled copies monitor them with department /li liEnsure employees onboarding on the different Quality Systems, Welcome Day and delivery-related training /li liMaintain employee's initials and personnel onboarding/termination up to date /li liDevelop 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…) /li liDrive continuous improvement of all QS processes /li liPrepare and maintain site Dashboards /li liPrepare KPIs extract and metrics follow-up to monitor Quality systems health and compliance with cGMP and internal applicable documents (including QMR metrics) /li liParticipate to internal audits /li liAct as QA approver or SME when necessary on changes, deviation, CAPA /li liParticipate, and lead when identified, QA Systems improvements projects /li liParticipate to inspection preparation, logistic and presentation /li liAt all times work in view of the site readiness for regulatory inspections (Swissmedic and International) /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 /ul h3REQUIREMENTS /h3 h3Qualification /h3 ul liMust speak, read write in both English and French /li liMust have 2 year of experience in a GMP environment including the use of e-systems (Biotech, pharmaceutical or equivalent industries) /li liGood understanding of basic GMP requirements related toQuality systemactivities (biopharmaceutical industry regulations and standards with Quality Systems) is a plus /li liGood Knowledge on quality system software (Veeva is a plus) /li liExperience in healthauthoritiesinspections is a plus /li liAbility to make pragmatic and compliant decisions /li liStrong result orientation and committed team member /li liExcellent written and verbal communication skills /li /ul h3Education /h3 ul liBachelor's Degree in relevant field such as Pharmacy, Chemistry, Biology or Bio-engineering, Bioprocessing is a plus /li liTrainer and/or auditor certification is a plus /li /ul pDelegate to: QA Specialist , QA Manager /p 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 /p #J-18808-Ljbffr