About this role
Overview SUMMARY With 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.
DUTIES AND RESPONSABILITIES · Act as a QA Admin and SME on eDMS and eQMS including Documentation, Retention/Archiving, Training, deviation & change control processes · Train users on documentation Management and Training systems, and support other training where necessary · Support actively system users in their daily tasks within the different quality systems · Act as key contact point for users at the Bioplant for specific troubleshooting. Escalate unresolved topics to Global QMS team when necessary · Manage the documentation change control process and Release Bioplant documentation and associated training · Maintain local training matrix and assign training within the e-DMS · Support Bioplant departments in the training strategy definition and maintenance · Responsible for local GMP documents filing and archiving system · Archive department paper document internally and be the point of contact for external archiving · Issue / reconciled controlled copies & monitor them with department · Ensure employees onboarding on the different Quality Systems, Welcome Day and delivery-related training · Maintain employee’s initials and personnel onboarding/termination up to date · Develop 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…) · Drive continuous improvement of all QS processes · Prepare and maintain site Dashboards · Prepare KPIs extract and metrics follow-up to monitor Quality systems health and compliance with cGMP and internal applicable documents (including QMR metrics) · Participate to internal audits · Act as QA approver or SME when necessary on changes, deviation, CAPA · Participate, and lead when identified, QA Systems improvements projects · Participate to inspection preparation, logistic and presentation · At all times work in view of the site readiness for regulatory inspections (Swissmedic and International) · Contribute positively to a strong culture of business integrity and ethics · Act within compliance and legal requirements as well as within company guidelines Delegate to: QA Specialist , QA Manager REQUIREMENTS Qualification : · Must speak, read & write in both English and French · Must have 2 year of experience in a GMP environment including the use of e-systems (Biotech, pharmaceutical or equivalent industries) · Good understanding of basic GMP requirements related to Quality system activities (biopharmaceutical industry regulations and standards with Quality Systems) is a plus · Good Knowledge on quality system software (Veeva is a plus) · Experience in health authorities inspections is a plus · Ability to make pragmatic and compliant decisions · Strong result orientation and committed team member · Excellent written and verbal communication skills Education : · Bachelor’s Degree in relevant field such as Pharmacy, Chemistry, Biology or Bio-engineering, Bioprocessing is a plus · Trainer and/or auditor certification is a plus Disclaimer: 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.
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