Validation Engineer/ Chuyên Viên Thẩm Định (Nhà Máy Dược Phẩm Bình Dương)

• 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 CAPA's, 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