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.
MINIMUM BACKGROUND/ EXPERIENCE REQUIRED
1. Education: Bachelor's degree
2. Years of experience, both overall and any industry-specific experience needed: More than 5 years of experience in Pharmaceutical industry or Medical devices
3. Other qualifications/certifications:
- Working in pharmaceutical company/ medical devices company and be familiar with international regulations
- Expert understanding of GxP regulations about validation, qualification, CSV
- Demonstrated ability to build the trusting relationships with management and other business stakeholders.
- Ability to initiate and drive organizational change in complex matrix environment, lead others through change, effectively manage resistance, and ensure organization engagement, influence and drive/ facilitate change across the organization.
- Teamwork and project management skill
- English: advance.
- Fluently Computer skills for office tasks