IVD Documentation Specialist
What are your responsibilities?
- Writes, edits, reviews and maintains high quality technical and scientific documentation including but not limited to:
- Technical protocols & reports (e.g. analytical assay vertification and validation)
- Product Specifications
- Change Reviews
- Design History File and/or technical file documentation regulatory submissions
- Briefing documents
- Quality System documentation including Standard Operating Procedures (SOPs), Instructions, Forms, etc.
- Provides support in development and review of documents from first draft stages through to an approved document, including:
- Document planning
- Interaction/communication with team members
- Resolution of comments errors and inconsistencies
- Timely facilitation of document review by stakeholders
- Supports the preparation and conduct of formal Design Review review meetings.
- Edits documents written by others to verify accuracy, consistency, grammar and format, and ensures document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
- Maintains standardized language and documentation practices that allow for consistent execution of documents.
- Participates in continuous quality improvement initiatives to drive organizational adoption of new tools and processes for content creation and management.
- Trains and educates cross-functional project team members on drafting documentation to required IVD standards.
- Provides additional support for project team activities as needed.
Who are we looking for?
- Master degree in sciences
- Minimum 3+ years IVD documentation and/or technical writing experience for a cGxP environement, preferably a Pharmaceuticals or Biotech company.
- Knowledge and experience with medical devices, regulated software, pharmaceutical or biotechnology industry preferred.
- Working knowledge with respect to the preparation of documents for submission for marketing approval.
- knowledge of current US and International regulations as it pertains to documentation (e.g. FDA, ISO, IVDD, and 21 CRF Part – 11) and control of electronic records is required
- Working knowledge of Design Controls, ISO13485 and 21
- Principles of effective scientific communication
- Basics in laboratory techniques (PCR), oncology or companion diagnostics is a plus
- Some background in statistics is preferred
- Quality mindset
- Able to organize and plan multiple priorities
- Fluent in English (oral and in writing), other European languages are an asset
- PC skills : Advanced MS Word, eDC systems an asset
What does QbD offer you?
- A young and dynamic company with a feel good culture, and a great openness and a no-nonsense approach
- Real investment in people through education and fun events
- A competence development model focused on your personal ambitions
- An attractive salary package
Interested? Apply now by sending us your CV and motivation.