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Sartorius • Incheon, South Korea
Role & seniority: Team Lead Quality; senior-level leadership (manages small group >5)
Stack/tools: eQMS; SAP; QA/RA tools (FMEA, impact assessment); IQ/OQ/PQ/PPQ/QMS documentation; calibration control systems
Set qualification and validation strategy for URS, DQ, FAT, SAT, IQ, OQ, PQ, PPQ for operational systems and manufacturing processes
Conduct/document risk assessments; manage CQV documents and records; investigate quality incidents with root-cause analysis and improvement plans
Support qualification/validation activities; maintain calibration control; coordinate with process owners and operators; prepare for health authority audits
Bachelor’s in engineering or related field; 10+ years in pharma/medical device with clean rooms/utilities
Strong documentation/record management; experience with health authority inspections/audits
English communication; leadership of small teams; cross-functional collaboration
Experience with eQMS and SAP; ability to work in multinational healthcare contexts
Experience in healthcare industry audits in multiple regions; self-motivated; interest in IT tools and new technology; entrepreneurial mindset
Location & work type: Not specified; implied full-time role with on-site qualification/validation activities in a healthcare/manufacturing environment; location to be confirmed
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 to our Candidate Portal and thank you for your interest in working and growing with us. We look forward to receiving your application. You can check the status anytime in this portal. Here you will find the best application tips from our HR team. Information on the application process can also be found in this video and under FAQ & Contact. In this brochure you will learn more about us as an employer and your career with us. For further insights, please visit the Sartorius Blog and our career website. Set up your personal Job Alert now and never miss an opportunity to apply for a job that suits you. Please note that you will receive an initial confirmation message. You'll need to confirm your selection to start receiving job alerts tailored to your preferences.