QMS Specialist
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 GMP & QMS training
- Ensure proper onboarding (training, systems access, documentation)
Operational Support
- Support users in daily use of quality systems
- Act as first point of contact for troubleshooting
- Escalate issues to global teams when needed
- Manage controlled copy issuance and tracking
Compliance & Continuous Improvement
- Ensure compliance with cGMP and internal procedures
- Drive continuous improvement initiatives within QMS processes
- Maintain KPIs and dashboards to monitor quality system performance
- Support and participate in:
- Internal audits
- Regulatory inspections (Swissmedic, international authorities)
Experience & Skills
- Minimum 2 years in a GMP environment
- Hands-on experience with Veeva required
- Strong communication skills (written & verbal)
- Ability to work in a compliant, pragmatic, and team-oriented way
Language
- Fluent in English and French (mandatory)
FAQs
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