Or client provides industry-leading pharma services solutions for drug development, clinical trial logistics and commercial manufacturing to customers of all sizes
This position is responsible for being the process validation representative to work with the external and internal clients.
- Perform all functions associated with process validation support.
- Author and perform the technical review of deviations and planned deviations, change controls, perform process monitoring, perform activities for lot release.
- Make recommendations for process changes and sponsors these to the larger process team.
- Identify potential root causes of variation and deviations using a systematic approach.
- Represent Process Validation on project teams and interfaces with customer technical and Quality representatives once a project has reached commercialization. Represents Process Validation on internal teams.
- Participate in Customer and Regulatory Audits. Regularly interact with site and global leadership on matters concerning several functional areas and/or customers.
- Work on CAPA and Deviations with minimal but some oversight to achieve quality, timely results.
- A bachelor degree
- At least 2 years experince in a similar role
- In depth knowledge of GMP
- Knowledgeable with statistical analysis and familiarity with a mainstream statistical software analysis program such as SAS, MiniTab, JMP, or Statistics.
- Knowledge of process validation principles and their application in biologics drug substance manufacturing.
If you are interested in this role, please contact me at firstname.lastname@example.org or at +31 20 658 98 00.