I’m working exclusively with my Biopharma Client in Belgium, which is in urgent need for an interim Analytical Methods Qualification & Validation Specialist to set up a new team. Reason for the role being open is due to setting up a new team; so an initial 6 month interim contract is offered to a suitable candidate. If interested, send your CV to g.paulusse@panda-int.com ASAP, since interview + offer will take place this week.
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
Understand customer needs and requirements to apply effective quality control method
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