Analytical Method Validation - Brussels, België - Panda International

Panda International

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Brussels, België

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Geplaatst door:

Sophie Dubois

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Analytical Method Validation & Qualification Specialist:

Location

Business Sector

Contact name

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Published

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:

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