Mô tả công việc
- Lead the implementation of the Quality Management System in compliance with ICH Q10 across the project lifecycle
- Develop and operate the system based on a risk management approach
- Manage key quality systems: validation, change control, deviation, CAPA, and OOS/OOT
- Develop the Validation Master Plan and Contamination Control Strategy
- Oversee qualification and validation activities (FAT, SAT, IQ, OQ) and computerized systems
- Evaluate, select, and manage suppliers and contractors
- Act as the Quality Assurance lead for technology transfer and operational validation
- Establish monitoring systems, including environmental monitoring, requalification, and product quality review
- Prepare for and lead inspections in accordance with European standards
- Manage post-inspection CAPA and hand over the system to operations
Yêu cầu
Education & Experience:
- Bachelor's degree in Pharmacy is mandatory; additional qualifications in Biotechnology or Microbiology are an advantage
- At least 7-10 years of experience in the pharmaceutical industry, including 3-5 years in a Quality Assurance supervisory or managerial role
- Proven experience in sterile manufacturing, preferably with beta-lactam products
Technical & Regulatory Knowledge:
- Strong knowledge of Quality Management Systems, including CAPA, Change Control, and Quality Risk Management
- Solid understanding of validation lifecycle and Good Manufacturing Practice auditing
- In-depth knowledge of sterile manufacturing processes and contamination control
- Expert-level knowledge of European Union and World Health Organization Good Manufacturing Practice guidelines, particularly Annex 1
Skills & Attributes:
- Strong attention to detail and systematic thinking
- Effective leadership and communication skills
- Ability to collaborate cross-functionally
- High commitment to quality, compliance, and continuous improvement
Quyền lợi
Khác
Competitive salary and attractive performance-based bonuses.
Opportunities to participate in strategic projects and contribute to the company's development.
Professional, dynamic work environment with opportunities for advancement.
Benefits according
Thông tin khác
NGÀY ĐĂNG
28/05/2026
CẤP BẬC
Trưởng phòng
NGÀNH NGHỀ
Sản Xuất > Đảm Bảo Chất Lượng/Kiểm Soát Chất Lượng/Quản Lý Chất Lượng
KỸ NĂNG
Quality Management, Quality Assurance, pharmaceutical, Biotechnology, CAPA
LĨNH VỰC
Dược phẩm
NGÔN NGỮ TRÌNH BÀY HỒ SƠ
Tiếng Anh
SỐ NĂM KINH NGHIỆM TỐI THIỂU
7
QUỐC TỊCH
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Thông tin chung
Nơi làm việc
- 31 Ngô Thời Nhiệm, Phường Xuân Hòa
- CCN Tân Ngại, Ấp Tân Ngại, Xã Song Lộc, Tỉnh Vĩnh Long (Trà Vinh cũ)
- Lô III-18 Đường CN13, KCN Tân Bình, Tây Thạnh
Cách thức ứng tuyển
Ứng viên nộp hồ sơ trực tuyến bằng cách bấm nút Ứng tuyển bên dưới:
Hạn nộp: 28/06/2026
