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Documentation Manager

Glomed Vietnam - Subsidiary of Abbott
Ngày cập nhật: 17/08/2017

Thông Tin Tuyển Dụng

Phúc lợi

  • Bảo hiểm theo quy định
  • Đào tạo
  • Chế độ nghỉ phép

Mô tả Công việc

  • Strong Understanding of Validation-Documentation.
  • Write/review/approve of protocols : URS; DQ; IQ; OQ; PQ protocols (this requires gaining an in-depth knowledge of the product to be able to determine what the necessary output is and if it is meeting predefined criteria).
  • Reports and make recommendations for changes and/or improvements and maintains appropriate validation documentation and files.
  • Functions as a liaison with project engineering, manufacturing and the customer regarding validation.
  • Coordinate, direct and lead validation including:

            + Process.
            + Computer System Validation (CSV) including Electronic Records &                      Electronic Signature Assessments, Risk Assessment, Supplier                              Assessment.
            + Equipment and Instrumentation Qualification.
            + Facility and Utility Qualification.
            + Testing of equipment.

  • Experience in GMP; EHS compliance; EU compliance; FAT; SAT.
  • Documenting and reporting the analysis of test results.
  • Other duties as assigned.: Safety/Environmental.

            + Where applicable, individual is pre-planning safety into work activities to             improve performance.
            + Proactively identifies safety concerns.
            + Complies with Environmental Management System program SOP’s,                Policy & Program elements and encourages responsible use of resources.

  • Completion of one of the following:

            + Submission of a continuous improvement idea.
            + Active participation in event.

  • Attending meetings, writing reports to managers.
  • Working independently with the inspector.
  • Should perform activities relating to validation such as thermal studies, cleaning, equipment and utility validation.
  • In order to execute protocol, they should often interact with the manufacturing sciences and other engineering departments.

Yêu Cầu Công Việc

  • Prefer candidates with 5 years of similar experience in validation-documentation for pharmaceutical industry.
  • Understanding of GMP; EHS compliance; EU compliance; FAT; SAT.
  • Strong coordination and communication skills across engineering departments.

Thông tin khác

  • Bằng cấp: Đại học
  • Độ tuổi: Không giới hạn tuổi
  • Hình thức: Nhân viên chính thức
  • Phúc lợi:

    - Attractive Salary & Bonus.
    - To work in the professional environmental, dynamic and having opportunities to was promoted.
    - Working from Monday to Friday every week.

Giới thiệu về công ty

Glomed Vietnam - Subsidiary of Abbott

Qui mô công ty: 1.000-4.999
Company profile: Abbott Vietnam was established in the year 1995. Since then, it has undergone extraordinary development and was soon perceived as one of...Chi tiết

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Documentation Manager

Glomed Vietnam - Subsidiary of Abbott

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