Our client is transferring a vaccine DP production to Puurs. To release Drug Product material and to supply OMCL, QC testing requires in house produced critical reagents (antibodies), internal control samples (DP), and Reference Standards (DP), together named RMCS (reference material and control standards. The client grange Castle will manufacture the critical reagents, and Puurs will characterize, qualify and bridge (equivalency testing) new lots of reagents.
As a PROJECT ENGINEER RMCS you will have the following responsibilities:
- The project engineer is required to routinely manage RMCS materials
- Qualify new lots
- File the qualification reports to the reg. Authorities
- Requalify the current lots
- Trending of control sample data
- They will aid in the implementation of the required processes and procedures to allow standardized management of RMCS, qualification, and requalification, implementation, inventory and trending analysis of control samples (data system, control charts, notifications and trending).
- They will effectively bridge the first wave of in house manufactured lots of RMCS, thus allowing Puurs to switch from GSK to Puurs supply of reagents