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
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- Lô III-18 Đường CN13, KCN Tân Bình, Tây Thạnh