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Mô tả công việc
• Responsible for temperature and humidity mapping and startup of new facility Controlled Temperature Units, Stability Chambers, Warehouse Space, storage room/area
• Provides validation schedule and prepare risk assessments for new systems and equipment introduced to the facility.
• Participation in the projects partially which related to the installations/ modification of systems that require validation/qualification works.
• Generate and execute validation protocols (IQ, OQ and PQ) for pharmaceutical drug manufacturing.
• Investigates and conducts troubleshooting/root cause analysis of deviations out of specification
• Perform validation activities for the facilities, utilities, manufacturing and laboratory equipment in the pharmaceutical industry
• Develop and write commissioning, qualification and validation documents following established standards and templates.
• Co-ordinate with relevant functions to prepares protocols for validation/ qualification: URS, FAT, SAT, DQ, IQ, OQ, PQ or performance testing of new or modified manufacturing equipment, processes, or systems.
• Supervising the current status of validation documentation in the scope of its activities
• Supervising the Validation master Plan and ensure the periodic validations are performed on time
• Resolves CAPA&039;s, non-conformances, protocol incidents, and change controls related to validation protocols.
• Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.
Yêu cầu
MINIMUM BACKGROUND/ EXPERIENCE REQUIRED
Core Skill Requirement
• Computer skills
• Time management skills and the ability to work on your own initiative
• Flexibility and adaptability
• Strong documentation and record-keeping skills
• Good communication skills in English and Vietnamese
• Problem-solving skills
• Analytical thinking
• Intermediate knowledge of utilities system (HVAC, purified water, compressed air, etc.) and manufacturing equipment of pharmaceutical industry, computerized system)
Core Trait/Behavior Requirement:
• Teamwork and working independently
• Patience in the workplace
MINIMUM EDUCATION REQUIRED
• Graduate or Undergraduate level
• Major in Mechanical or Electrical Engineering
Quyền lợi
Laptop, Phụ cấp, Xe đưa đón, Chế độ thưởng, Đào tạo, Tăng lương, Nghỉ phép năm
Thông tin khác
Thông tin tuyển dụng
Việc làm tại: Bình Dương
Mức lương:Cạnh tranh
Hạn nộp hồ sơ: [protected info]Chức vụ: Nhân Viên
Hình thức: Nhân viên chính thức
Kinh nghiệm: 3 - 6 Năm
Số lượng: Đang Cập Nhật
Trình độ: Đại Học
Thông tin chung
- Ngày hết hạn: [protected info]
- Thu nhập: Cạnh tranh