Quality System Specialist (QA Admin)

About the role

This position reports to the Quality Assurance team and supports the Quality System activities and operations linked to maintaining a Quality Management System at a large-scale API bio-manufacturing facility. It covers the management and maintenance of quality systems under quality policies, cGMP, Swiss, EU and US FDA regulations, with a focus on training, documentation, personnel management, retention/archiving, deviations and change control.

Key responsibilities

• Act as QA administrator and subject matter expert on eDMS and eQMS, covering documentation, retention/archiving, training, deviations and change control.
• Train users on documentation and training systems, support daily tasks and act as first contact for troubleshooting, escalating unresolved issues to the Global QMS team.
• Manage documentation change control, release Bioplant documentation and training, and maintain the local training matrix.
• Support departments in defining and maintaining the training strategy, and handle local GMP document filing and archiving, including paper documents and controlled copies.
• Onboard employees to quality systems, keep personnel records up to date, and deliver QMS training on good documentation practices, cGMP and eDMS roles.
• Prepare site dashboards, KPIs and metrics to monitor quality system health and compliance, and take part in internal audits and inspection preparation.
• Act as QA approver or SME on changes, deviations and CAPA, and contribute to QA system improvement projects.

Required profile

• Bachelor's degree in a relevant field such as pharmacy, chemistry, biology or bio-engineering; bioprocessing is a plus.
• Two years of experience in a GMP environment using e-systems (biotech, pharmaceutical or equivalent).
• Fluent speaking, reading and writing in both English and French.
• Good knowledge of basic GMP requirements and quality system software (Veeva is a plus); experience with health authority inspections is a plus.
• Trainer and/or auditor certification is a plus.

Required skills

• Basic GMP requirements and quality system activities
• e-systems in a GMP environment
• Quality system software (Veeva is a plus)