Description
NextLink are currently working with a leading pharmaceutical organisation who are seeking a QMS Project Co-Ordinator for their Barcelona offices on an initial 6-month contract.
The Role
- Understand the regulatory framework for the different types of applications and procedures
- Own the Project Documentation plan, follow up documentation completeness, y
- Manage document´s lifecycle Document management system, upload documents, manage and follow up workflow
- Provide status update to stakeholders on documentation plan
- Work with Quality team to define documentation plan for releases
- Maintain project documentation updated in repositories
- Ensure Documents follow quality standards of formatting and content
- Extract and create documents from Jira
- Lead /contribute to the planning, preparation of documents and delivery of submissions throughout the product's life cycle
- Coordinate the input, maintenance, and revision in the Digital project plans for assigned projects
- Identify regulatory risks on documents timeline and propose mitigations to Project Manager and teams.
- Ensures monitoring and evaluation of generated documentation.
- Collaborate in writing and updating end technical and functional documentation
Experience Required
- Extensive Project management/coordination experience
- Proven experience in Technical writing for software applications
- Proven experience with Confluence, JIRA, Windchill
- Familiarity with software development processes.
- Fluent English and Spanish
- Regulatory experience within the pharma/health industry would be a bonus