Consultant – Quality Lead, Global Regulatory Affairs
France
Full Time
3 hours ago
Key skills
Remote Work
About this role
Role Overview
- Develop the annual quality plan
- Manage quality documentation (SOPs / OPMs)
- Review procedures prior to approval to ensure compliance with the QMS
- Support and assist business teams in drafting procedures
- Manage roles and assignment of quality documents
- Develop training materials
- Monitor and calculate QMS indicators and metrics
- Track and follow up on deviations, CAPAs and change controls
- Participate in inspection activities and in interactions with quality systems
Requirements
- Minimum 5 to 10 years' experience in the pharmaceutical industry
- Strong knowledge of Quality Management Systems and GxP requirements
- Experience in quality within Regulatory Affairs is preferred
- Proven experience in quality document management
- Education: scientific background (pharmacy, life sciences or equivalent)
- Written and spoken English
Benefits
- Possibility of remote work