QA Documentation and Training Specialist

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von: AXEPTA SA | localité: LausanneN: AXEPTASA

My client an international pharmaceutical company is looking for a Specialist QA documentation and Training to join them in their office in Vaud canton.

This position supports the Quality System activities and related operations associated with the development and the maintenance of a Quality Management System for the biomanufacturing 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, Retention/Archiving, audits.


QA Documentation and Training Specialist



  • Act as a QA Admin and SME on eDMS and eQMS including Documentation, Retention/Archiving and Training 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
  • Support Bioplant departments in the training strategy definition and maintenance
  • Ensure employees onboarding on the different Quality Systems and deliver related training
  • Act as key contact point for users at the Bioplant for specific troubleshooting. Escalate unresolved topics to Global QMS team when necessary
  • Drive continuous improvement of Documentation and Training 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
  • Maintain employee’s initials and personnel onboarding/termination up-to-date.
  • Responsible for local GMP documents filing and archiving system
  • Manage the documentation change control process
  • Release Bioplant documentation and associated training
  • Maintain local training matrix and assign training within the e-DMS
  • 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…)
  • Maintain local procedures and WI related to Documentation and Training processes (eDMS/eLMS) up to date and align with Global QA requirements
  • Participate to internal audits and maintain internal audit plan
  • Act as QA approver or SME when necessary on changes, deviation, CAPA
  • Act as QA SME for documentation and training processes
  • 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)

Your profile :

  • Bachelor’s Degree in relevant field such as Pharmacy, Chemistry, Biology or Bio-engineering, Bioprocessing is a plus
  • Trainer certification is a plus
  • 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 documentation and training activities (biopharmaceutical industry regulations and standards with Quality Systems) is a plus
  • Ability to make pragmatic and compliant decisions
  • Strong result orientation and committed team member
  • Excellent written and verbal communication skills