LSC have an exciting Opportunity available for a FAT Co-Ordinator to join a large pharmaceutical company in Germany. The role requires the person to be stationed in Germany close to the supplier conducting the FAT during this duration of 8 FATs.
Role & Responsibilities
- Being physically present on the floor at supplier where the FAT is conducted and keeping track of the different FAT test being conducted.
- Reporting to and aiding the Lead FAT coordinator present in the program (in Denmark) with day to day progress of tests in FAT.
- Assisting the supplier in running daily interface meetings between Novo Engineering Responsible(s) and supplier qualification counterparts.
- Participating in FAT tests along with Novo ERs and creating additional documentation for Novo when deemed necessary by the ERs.
- Witnessing particular FAT tests conducted by the supplier in those instances where a Novo ER is not present and ensuring that the tests are conducted according to correct standards.
- Keeping tracks of other Filling lines in construction / testing phases on the supplier floor and performing oversight activities according to the structure / requirements set by the ERs.
Education & Experience
- Previous experience in leading or participating in FATs of GMP machineries, preferably Aseptic Filling machines.
- Good understanding of Engineering and GMP principles.
- Good communication skills and stakeholder engagement.
Note: Are you currently eligible to work in Germany? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Sarah Ninan @02147777329 if you have any more questions about this opportunity!
