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Validation Manager, Abbott Healthcare Viet Nam

Abbott · Bình Dương
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Loại hình
Toàn thời gian
Hình thức
Tại văn phòng
Cấp bậc
Trưởng / Phó phòng
Ngành nghề
Ngành nghề khác
Mức lương
Thương lượng
Địa điểm
Bình Dương, Bình Dương, Bình Dương

Tổng quan

  • Career development with an international company where you can grow the career you dream of.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
  • Report to: Head of Quality
  • Working Location: VSIP 1, 35 Tu Do Boulevard, Vietnam Singapore Industrial Park
  • Leading the validation activities at site level to achieve the regulatory requirements (PIC/S, EU GMP)
  • Coordinate and Strengthen the Validation team which contributed from different functions at Site to fulfill all validation and qualification tasks and requirements
  • Optimizing the validation/ qualification activities to achieve the sustainability in the validation/ qualification system to support for the business in future.
  • Core job responsibilities for Validation management within organization
  • Supervisory/ Management Responsibilities cross-functional collaboration on site projects related qualification/ validation
  • Position Accountability/ Scope Accountable for annual validation budget forecasting, implementation and monitoring.
  • Perform other validation jobs which assigned by Quality Head, including but not limited
  • Creating strategy for Validation management and implementation within organization
  • Development project plan and management and participate in all areas of a project: Deliver project status reporting, KPI uploads as necessary
  • Knowledge and implement about PIC/S EU-GMP, WHO GMP, US FDA guidelines
  • Develop and planning Validation Strategy, schedule
  • Follow up and support other function to compliance with guideline and regulations from ICH, ISO, ISPE, GMP
  • Leading risk management process for Validation and Qualification scope
  • Develop, maintain, and manage relationships with functions and run project as a coordinator
  • Drive, measure and analyze performance against key project metrics
  • Develop and focus on planning strategy and management
  • Managing project progress and adapt work as required
  • Develop validation plans and risk management plans
  • Familiar with using data to produce reports on content performance
  • Review and approve plan of equipment/ facility/ utility qualification, cleaning validation, analytical method validation, computerize system validation (except validation master plan approved by line manager)
  • Review and approve the risk assessment for the qualification/ validation/ requalification/ revalidation (except critical/ high risk approved by line manager)
  • Review and approve all the documents related to the equipment/ facility/ utility qualification/ requalification (URS, FRS, DQ, IQ, OQ, PQ) (except the final qualification report approved by line manager)
  • Review and approve all the documents related to cleaning validation, analytical method validation, computerize system validation of Production/ Engineering/ Warehouse/ Quality control department (except the final qualification report approved by line manager)
  • Ensure cross-functional collaboration on site projects related qualification/ validation
  • Lead the establishment of performance project scorecard
  • Lead and define project management
  • Experience working with international partners tools
  • 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
  • Accountable for annual validation budget forecasting, implementation and monitoring.
  • Accountable for join as a core team member to Site Strategy Project
  • To involve in the FAT for new equipment/ instrument/ utilities and system if applicable
  • Support to prepare the PQ protocol for production equipment (if required)
  • Support to prepare the PV protocol (if required)
  • To provide all required support for validation/ qualification (if required)
  • Update procedure relate equipment/ facility/ utility qualification (procedure of equipment, facility and utility qualification; moist heat sterilization process design and validation…)

Quyền lợi

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