Validation Engineer/ Chuyên viên Thẩm định nhà máy Dược Abbott

Báo lỗi

☞ Abbott

Lượt xem: 171

Ngày cập nhật: 14-04-2024

Địa điểm: Bình Dương

Ngành nghề: Quản lý chất lượng (QA/QC) Dược Phẩm/ Hóa học/ Sinh học

Vị trí: Nhân viên

Mức lương: Cạnh tranh

Trình độ: Đại học

Kinh nghiệm: 3 - 6 Năm

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Mô tả công việc

• Supervising the Validation master Plan and ensure the periodic validations are performed on time
• Supervising the current status of validation documentation in the scope of its activities
• Participation in the projects partially which related to the installations/ modification of systems that require validation/qualification works.
• Responsible for temperature and humidity mapping and startup of new facility Controlled Temperature Units, Stability Chambers, Warehouse Space, storage room/area
• Resolves CAPAs, non-conformances, protocol incidents, and change controls related to validation protocols.
• Provides validation schedule and prepare risk assessments for new systems and equipment introduced to the facility.
• 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.
• Perform validation activities for the facilities, utilities, manufacturing and laboratory equipment in the pharmaceutical industry
• Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.
• Develop and write commissioning, qualification and validation documents following established standards and templates.
• 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

Yêu cầu công việc

MINIMUM BACKGROUND/ EXPERIENCE REQUIRED
Core Skill Requirement
• Strong documentation and record-keeping skills
• Analytical thinking
• Good communication skills in English and Vietnamese
• Computer skills
• Flexibility and adaptability
• Time management skills and the ability to work on your own initiative
• Problem-solving skills
• 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 công việc

  • Laptop
  • Phụ cấp
  • Xe đưa đón
  • Chế độ thưởng
  • Đào tạo
  • Tăng lương
  • Nghỉ phép năm
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Hạn nộp: 14-05-2024

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