Responsible for establishing and qualifying QC laboratories
Serve as a subject matter expert in laboratory setup, method transfer and method validation.
Provides technical input and documentation support for Qualification activities.
Collaborate with internal and external partners to ensure QC readiness and compliance with global standards.
Main Responsibilities & Tasks:
- Participate in the establishment of the new QC laboratory, including furniture installation and laboratory equipment qualification (IOQ).
- Prepare/Support and execute protocols and reports for QC Equipment qualification.
- Support quality monitoring plans to maintain clean utility (WFI, clean steam, liquid nitrogen, HVAC etc.) attributes are meeting required specifications.
- Support cleanroom qualification and monitoring plans (viable and non-viable particles) based on risk analysis and aligned with global standards
- Provide technical input and documentation support for Phase I, II, III qualification protocols during facility start-up.
- Support strategies set up for microbial testing (microbial limit, sterility, endotoxin, etc.) based on risk analysis of product, environment, and process.
- Review and support method transfer, validation, and related documentation.
- Prepare local procedures for environmental and product monitoring & control (viable and non-viable particles).
- Design and standardize sampling scheme, test scheme and procedures as SOP/WI.
- Contribute process improvement.
- Communicate with contract laboratories and external partners for technology transfer.
- Collaborate with internal departments (Quality, Engineering, Construction) and external partners (contract labs, vendors) to ensure readiness of QC laboratory and clean facility and utility system
Qualification & Skills:
- Minimum of a Bachelor’s degree in Microbiology, or related to life science
- At least 3~5 years’ experience in QC laboratory within pharmaceutical/biotechnology industry.
- Proven experience with QC Lab set-up, Equipment IOQ, and Cleanroom qualification test.
- Experience in microbiological testing (Bioburden, Endotoxin, Sterility).
- Experience in EM (environmental monitoring) and WM (water monitoring) sampling and testing.
- Hands-on experience with method transfer and method validation.
- Strong skills in risk assessment and problem-solving methodologies
- Good communication and documentation skills; English reading/writing capability preferred.
- Project participation experience related to facility qualification is a strongly preferred.
- 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