Job Description
The QMS Specialist works within the Quality Assurance team to support and manage the Quality Management System in a pharmaceutical manufacturing environment.
The role ensures compliance with cGMP standards and regulatory requirements (Swiss, EU, FDA) and focuses on maintaining and improving key quality processes such as documentation, training, deviation management, and change control.
Key Responsibilities
Quality Systems Management
- Act as SME administrator for Veeva eDMS and eQMS
- Manage QA processes:
- Documentation & controlled copies
- Training systems
- Deviation & change control
- Archiving & retention
Documentation & Training
- Oversee document lifecycle (creation, review, approval, release)
- Manage document change control process
- Maintain training matrices and assign training
- Develop and deliver ...