Tổng quan 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...
Kỹ năng chính
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...
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 bổ sung
QA, Dược
Đại học, Thac Si
