I'm working exclusively with my Biopharma Client in the Netherlands, who is in urgent need for an interim QC Consultant to set up a a new project. Reason for the role being open is due to setting up a new team; so an initial 9 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: 9 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 & Dutch
Interview process: 1 stage interview process via Teams