Analytical Methods Qualification

Eurogentec is an internationally recognized biotechnology companygroup, part of the Kaneka Group. For several decades, the company has been a global provider of innovative products and services for the life sciences industry. The company has developed a broad technology platform, which is organized into separate business units, subsidiaries and production facilities. We are looking to enter immediately for the Biologics department a (M/F):
Analytical methods Qualification & Validation Project Leader:
In order to reinforce its structure and to answer to an increasing demand in terms of qualification and validation of analytical methods, a new role within the QC GMP has been created. The incumbent will report directly to the analytical methods Qualification & Validation Manager and will be part of a team of about 5 people.

**The main responsibilities of the function include**:

- 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
- Accountable for regulatory / customers audits linked to Q&V
- 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
- Ensure adherence to the updated guidelines linked to Q&V

**Your profile**
- Ph.D, MS, Pharmacist, biochemistry and/or molecular biology with at least 5 years of experience.
- Experience within a CDMO is a plus
- Strong knowledge of GMP rules/data integrity/trouble shooting
- Demonstrated experience as a good team player
- Strong knowledge and expertise in development, validation of analytical methods applied to protein and plasmid products
- Customers-oriented

**Your skills**
- Very good knowledge of analytical processes from method development to release
- Very good knowledge of guidances for method development, qualification & validation
- Familiar with the analytical Quality by Design approach
- Good knowledge of statistical analysis applied for analytical methods
- Ability to communicate in English (oral and written)
- Solutions oriented and continuous improvement mindset

**Our offer**
- The opportunity to work:
oIn a growing and innovative company in the heart of the Province of Liège.
- oWithin a young and friendly team, in a flexible and dynamic environment.- An open-ended employment contract with a salary based on your experience, with extra-legal benefits.