Abbott

Makes heart devices, glucose sensors and lab tests

Validation Manager

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours

Full-timeThuận An, Binh Duong, VietnamNo salary listed

About the Job

Requirements

A university degree in Chemistry or Pharmacy.
Knowledge of validation and qualification of factories, equipment, machinery, active pharmaceutical ingredients, excipients, manufacturing procedures, cleaning procedures, and computerized systems.
Understanding of WHO-GMP, PIC/S-GMP, and EU-GMP processes in the pharmaceutical industry.
More than 5 years of experience in the pharmaceutical industry or medical devices, with experience in validation and qualification.
Mastery of validation and qualification concepts, requirements, and methods.
Ability to use Microsoft Office.
Ability to use English.
Ability to manage time and organize work.
Ability to build trusting relationships with management and business stakeholders.
Ability to initiate and drive organizational change in a complex matrix environment, lead others through change, manage resistance, and foster organizational engagement and influence.
Teamwork, project management, and communication skills, and ability to enable people to achieve results.
Leadership skills.

Responsibilities

Lead site-level validation activities to meet regulatory requirements, including PIC/S and EU GMP.
Coordinate and strengthen the cross-functional site validation team to fulfill validation and qualification tasks and requirements.
Optimize validation and qualification activities to support a sustainable system and future business needs.
Manage validation activities across the organization, including supervisory responsibilities and cross-functional collaboration on site qualification and validation projects.
Forecast, implement, and monitor the annual validation budget.
Perform other validation duties assigned by the Head of Quality.
Create and implement the organization’s validation management strategy.
Develop project plans, manage projects, participate across project areas, report project status, and upload key performance indicators as needed.
Implement and apply PIC/S, EU-GMP, WHO GMP, and U.S. FDA guidelines.
Develop validation strategies and schedules.
Support other functions in complying with guidelines and regulations from ICH, ISO, ISPE, and GMP.
Lead risk management for validation and qualification scopes.
Develop and maintain relationships with functions and coordinate projects.
Measure and analyze performance against key project metrics.
Plan and manage strategy and work priorities.
Manage project progress and adapt work as required.
Develop validation plans and risk management plans.
Use data to produce reports on content performance.
Review and approve plans for equipment, facility, and utility qualification; cleaning validation; analytical method validation; and computerized system validation, except validation master plans approved by the line manager.
Review and approve risk assessments for qualification, validation, requalification, and revalidation, except critical or high-risk assessments approved by the line manager.
Review and approve equipment, facility, and utility qualification and requalification documents (URS, FRS, DQ, IQ, OQ, and PQ), except final qualification reports approved by the line manager.
Review and approve documents related to cleaning validation, analytical method validation, and computerized system validation for Production, Engineering, Warehouse, and Quality Control, except final qualification reports approved by the line manager.
Ensure cross-functional collaboration on site qualification and validation projects.
Establish a project performance scorecard and define project management.
Collaborate with regional and divisional subject-matter experts to improve site validation knowledge; train departmental validation teams in professional knowledge and audit readiness.
Participate as a core team member in the Site Strategy Project.
Participate in factory acceptance testing for new equipment, instruments, utilities, and systems when applicable.
Support preparation of production equipment performance qualification protocols when required.
Support preparation of process validation protocols when required.
Provide required support for validation and qualification activities.
Update procedures related to equipment, facility, and utility qualification, including moist heat sterilization process design and validation.

Desired Qualifications

Experience working with tools used by international partners.

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)

About the Company

Abbott

Makes heart devices, glucose sensors and lab tests

Abbott makes medical devices, diagnostic tests, nutrition products and branded generic drugs for hospitals, laboratories, pharmacies and patients. Its best-known product is the FreeStyle Libre, a coin-sized sensor worn on the upper arm that tracks blood sugar around the clock without routine finger pricks. Its other lines run from heart valves, pacemakers and brain stimulators to lab analyzers, rapid tests and mail-in colon cancer screening kits, and Abbott earns money by selling these products to health systems, labs, retailers and consumers. The company was founded in 1888 by Chicago physician Wallace Abbott and is based in Abbott Park, Illinois.

Company size: 10,001+
Company stage: IPO
Headquarters: Abbott Park, IL
Founded: 1888

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