工作内容
You have broad knowledge and demonstrated experience with CMC of biologicals? You have affinity with Regulatory Affairs and knowledge of Quality Control?
This opportunity might interest you!
3 years’ experience and at least 1 years in a similar position. This is a scientist position, sono need of management experience.- Broad knowledge and demonstrated experience with CMC of biologicals
- Demonstrated affinity withRegulatory Affairs
- Knowledge of Quality Control, including tests, method validation principles
- Self-starter, dynamic and excellent communicator
- Excellent analytical skills and ability to go from detail to big picture with a good level of assertivity
- Fluent English and French is required
- Able to work independently, but no solo player
Possibility of working remotely
We offer an attractive salary with extra-legal advantages:
Group insurance- Hospitalisation insurance
- Meal vouchers of 7 euros gross per working day
- Reimbursement km or company car
- Monthly allowance (50 euros net per month)
- A 13th month
- Training
- Etc
- A rate as freelance is also possible
Our customer is a company that offers innovative solutions in the field of biomanufacturing
Context: The consultant will perform a temporary mission within the QC team of our client. The focus is on writing specification sheets of raw materials, starting materials, consumables and drug substance that are used/produced in the context of a gene therapy production process. This involves requesting and evaluating technical and regulatory type of information from the suppliers, and translating that in justified specification sheets that are used for the release testing of these materials.
Reporting to: Head of QC
Interactions:
- Internally with Qualified Person, Quality Assurance, Production, Procurement, QC Scientists, CMC expert
- Externally with various suppliers
最后期限: 31-12-2025
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