Analytical Method Validation
Il y a 5 mois
**Analytical Method Validation & Qualification Specialist**:
**Location**
- Liège, Belgium
**Business Sector**
- Biotechnology
**Contact name**
- Guus Paulusse
**Job ref**
- 20630
**Published**
- 8 months ago
**Start Date**: ASAP /
**Duration**: 6 Months /
**Hours**: 40 per week (2 days working from home is possible)
**Responsibilities**:
- Support the Manager in the strategy of qualification & validation (Q&V) to have fit for purpose analytical methods (implementation of the total error approach)
- Define design studies for qualification & validation
- Write protocols, reports and compile the data
- Make statistical analysis linked to Q&V
- Interact with the analytical development department (PTD) to strengthen the analytical Quality by Design (aQbD) approach
- Check GMP documentation (protocols, rapport) generated by the other Q&V project leaders (PL)
- Support the QC laboratory in case of method troubleshooting
- Interact with the customers/subcontractors
- Manage deviations linked to the Q&V activities
- Ability to discuss and challenge the strategy, results (included statistical analysis) and conclusions obtained during qualification/validation
- Ensure that quality documents are properly delivered on time internally and to the customers
- Be on the lookout for opportunities for improvement and develop new efficient way of working
**Experience**:
- Ph.D, MS, Pharmacist, biochemistry and/or molecular biology with at least 5 years of experience
- Strong knowledge and expertise in development, validation of analytical methods applied to protein and plasmid products
- Strong knowledge of GMP rules/data integrity/trouble shooting
- Experience within a CDMO is a plus
- Languages: English & French
**Interview process**: 1 stage interview process via Teams
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