Validation Engineer/ Chuyên viên Thẩm định nhà máy Dược Abbott

Erreur

☞ Abbott

Vue: 174

Jour de mise à jour: 14-04-2024

Localisation: Binh Duong

Catégorie: Assurance Qualité / Contrôle Qualité Pharmaceutique / Chimique / Biotechnologie

Niveau: Nhân viên

Salaire: Cạnh tranh

Éducation: Đại học

Expérience: 3 - 6 Năm

Đang tải ...

Description de l’emploi

• 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

Exigences de l’emploi

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

Bénéfice d’emploi

  • Laptop
  • Phụ cấp
  • Xe đưa đón
  • Chế độ thưởng
  • Đào tạo
  • Tăng lương
  • Nghỉ phép năm
Đang tải ...

Date limite: 14-05-2024

Cliquez pour postuler pour un candidat gratuit

Postuler

Đang tải ...
Đang tải ...

MÊMES EMPLOIS

Đang tải ...
Đang tải ...