SartoriusQuality Engineer-Q&V
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 plan with qualification and validation strategy.
- Support qualification and validation activity with owner or operators.
Qualification & Skills:
- Bachelor’s degree in engineering related.
- Min. 10 years’ well-proven work experience in pharmaceutical/medical device industry using clean rooms and clean utility.
- Strong at documentation/record management
- Experienced with health authority or notification body inspection/customer audit in healthcare industry
- English communication capability
- Leadership experience in managing small groups of more than 5 people
- Excellence communication skills to facilitate cross functional organization
- Work experience work in or with multinational healthcare industry
- Experienced with eQMS and SAP based work environment
- Self-motivated, entrepreneurship, enjoying exploring new technology (IT tools)
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application. www.sartorius.com/careers