Specialist Quality System

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

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