For our client, we are seeking a Process Specialist to coordinate and execute site activities within the MSAT (Manufacturing Science and Technology) department.
Your Role :
- Coordinate with the project stakeholders the site activities for new product introductions, technology transfer (TT), validation of processes or process changes for commercial products.
- Ensure coordination of production activities on the shop floor falling under your responsibility.
- Write documentation related to process validation, change controls and batch record for the manufacturing of products under your scope.
- Lead investigations and troubleshooting efforts in collaboration with quality and production teams.
- Develop and maintain strong relationships with internal stakeholders including production, Quality unit, and technical services.
- Ensure appropriate documentation and data management using corresponding IT system, including QMS softwares (TrackWise, ManGo, GLIMS), ERP (SAP).
- Ensure that all related activities are carried out at required quality / GMP standards