Found Description
The Team Lead Quality will be responsible for maintaining operational system (facility, utility, process equipment etc.) and processes are qualified and validated to meet their requirement together with system, process owners.
Main Responsibilities & Tasks:
+ Set qualification and validation strategy for URS, DQ, FAT, SAT, IQ, OQ, PQ and PPQ of operational system and manufacturing process with process owner to meet required specification complying applicable Sartorius internal standard together with system owners.
+ Conduct & document risk assessment of above-mentioned system together with system owner following defined Sartorius’ RA tool. (FMEA or Impact Assessment etc.)
+ Manage Commissioning, Qualification and Validation document and records
+ Set up and maintain instrument’s calibration control system
+ Investigate Quality incident, deviation, complaint together with owners to find root cause and come up with improvement p...
Main Responsibilities & Tasks:
+ Set qualification and validation strategy for URS, DQ, FAT, SAT, IQ, OQ, PQ and PPQ of operational system and manufacturing process with process owner to meet required specification complying applicable Sartorius internal standard together with system owners.
+ Conduct & document risk assessment of above-mentioned system together with system owner following defined Sartorius’ RA tool. (FMEA or Impact Assessment etc.)
+ Manage Commissioning, Qualification and Validation document and records
+ Set up and maintain instrument’s calibration control system
+ Investigate Quality incident, deviation, complaint together with owners to find root cause and come up with improvement p...