Lead and manage all QC operations for plasma-derived biological products and sterile injectable drugs.
Develop and implement QC strategies, systems, SOPs, and test methods aligned with EU-GMP / WHO-GMP / PIC/S standards.
Oversee analytical testing, microbiological testing, environmental monitoring, and stability testing.
Coordinate with QA, Production, R&D, and Regulatory Affairs to ensure product quality and compliance
Review and approve COAs, batch release data, and laboratory documentation.
Handle out-of-specification (OOS), deviations, CAPA, and change control.
Lead audits, inspections, and support GMP certification processes.
Manage and train QC team to maintain high performance and continuous improvement.
Report directly to the Quality Director or General Director.
Yêu Cầu Công Việc
Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related field.
Minimum 7 - 8 years of experience in the pharmaceutical industry, with at least 3 - 5 years in a managerial QA/QC role in injectable or plasma product manufacturing.
In-depth knowledge of international quality standards: EU-GMP, WHO-GMP, PIC/S, FDA.
Proficient in English (speaking, reading, writing); German or French is a plus.
Strong leadership, communication, problem-solving, and organizational skills.
Preference given to candidates with experience in GMP certification, technology transfer, or working at export-standard facilities (EU/US markets).
Thời gian làm việc: Monday - Friday ( 8am - 5pm); Saturday (8am - 12am)
Đồng nghiệp: Respectful & Understanding
Phúc lợi:
• Attractive and competitive salary, negotiable based on experience and qualifications.
• Full social insurance, health insurance, paid holidays, and annual company trips.
• Housing and transportation support (for foreign experts or relocation needs).
• Opportunity to work in a pioneering company in
