Validation Manager, Abbott Healthcare Viet Nam

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• •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.

Job Summary:

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

- 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

- Coordinate and Strengthen the Validation team which contributed from different functions at Site to fulfill all validation and qualification tasks and requirements

- 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…)

Job Requirements

• •University (Chemistry or Pharmacy)
• •There’s a knowledge about validation, qualification of factory, equipment, machinery, API, excipients, manufacturing procedure, cleaning procedure, computerized system...
• •Understanding the systematic process of WHO-GMP, PIC/S -GMP, EU-GMP, in the pharmaceutical industry.
• •Experienced in validation/qualification. More than 5 years of experience in Pharmaceutical industry or Medical devices
• •To master concepts, requirements and ways of validation/qualification.
• •Ability to use MS office
• •Ability to use English
• •Time management, organize working
• •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
• •Team work and project management skill, communication skills, enable people to result
• •Leadership skills

The base pay for this position is

N/A In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

EPD Established Pharma

LOCATION:

Vietnam > Thuan An : Binh Duong Plant 1

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)