Validation Manager - Abbott Healthcare - Binh Duong

Mô tả Công việc
VIETNAM EPD PLANT OVERVIEW
At Abbott, we believe that the access to high-quality, trusted branded generics is essential to the success of patients' treatment all over the world. That's why our business brings value to its patients and customers through deep localization and a growing portfolio of high-quality established pharmaceutical products. As the leader in branded generics, we serve the people in emerging markets across the continuum of their lives. We commit our talent and enthusiasm to earn our customers trust by providing innovative, affordable medicines and healthcare solutions.
In Vietnam, Abbott's Established Pharmaceuticals Division has committed to enhance the care of patients. Our products cover several therapeutic areas, including gastroenterology, women health, cardiology, primary care, specialty and food supplement. Our key prescription products include Lipanthyl, Klacid, Duphaston, Drosperin and BetaSerc. Our key over-the-counter products are Duphalac, CG210, Estraceptin, Brufen, Fatig, Surbex. We also have the Influvac vaccine.
ROLES & RESPONSIBILITIES
1. Lead the validation activities at site in high compliance status with current requirements. Coordinate and Strengthen the Validation team which contributed from different functions at Site to fulfill all validation and qualification tasks and requirements.
2. Review and prepare the validation/ qualification readiness to adapt PIC/S and EU GMP requirements.
3. Optimizing the validation/ qualification activities with the high compliance status to support the business.
4. Collaboration with regional/ divisional SME to improve the validation knowledge at site, training the validation team from departments about the professional knowledge and audit readiness for validation.
5. Perform additional duties as assigned in support the validation system such as key contact of Validation SME network, internal audit for validation...
6. Review and approve equipment/ facility/ utility qualification plan.
7. To perform or review risk assessment for the equipment/ facility/ utility qualification/ requalification/ validations.
8. Review and approve all the documents related to the equipment/ facility/ utility qualification/ requalification (URS, FRS, DQ, IQ, OQ, PQ)/ the computerize system validation/ Cleaning validation, Analytical method validation including the final qualification report.
9. To involve in the FAT for new equipment/ instrument/ utilities and system if applicable.
10. Monitors the process to perform IQ, OQ, PQ.
11. To provide all required support for validation/ qualification (if required).
12. Update procedure relate equipment/ facility/ utility qualification (procedure of equipment, facility and utility qualification; moist heat sterilization process design and validation).
13. Review all the documents related to the computerize system validation, including the final qualification report.