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Mô tả công việc
Mô tả Công việc
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
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).
Quyền lợi
Chế độ bảo hiểm
Du Lịch
Xe đưa đón
Chế độ thưởng
Chăm sóc sức khỏe
Đào tạo
Tăng lương
Phụ cấp thâm niên
Nghỉ phép năm
Thông tin chung
- Ngày hết hạn: 22/06/2025
- Thu nhập: Cạnh tranh
Nơi làm việc
- 62/36 Trương Công Định, Phường 14, Tân Bình, Hồ Chí Minh