Document Control Coordinator

- PRODUCTION POSITIONS -

  • 1. Document standardization, Document control system (50%).

    2. Continuous improvement (Kaizen) Program (30%)

    3. Main Tasks assigned by LEAN Manager (20%)

  • · (50%)

    - Manage the quality document/record system at production.

    - Create, update document control procedures, and assist in implementing the quality document control requirements to comply with corporate & ISO standards and the regulatory requirements

    - Assist in creating, revising, and maintaining the currently controlled documents including guiding the controlling of document change requests, document change orders processing, specification, and process changes, protocols, etc.

    - Issue, distribute, and update the hard copies of the controlled documents

    - Create and maintain a master list of documents, SOPs, work instructions, etc. in a controlled documents database, ensure accuracy and completeness,

    - Maintain, inspect periodically data to ensure the record traceability and document control

    - Retain/ archive document history records, obsolete documents, and quality records following Quality System requirements.

    - Assist in completing registration records according to regulatory affair requirements.

    - Coordinator with QC team for document standardization, roll out to production.

    · (30%)

    - Update production report on system

    - Weekly/ Monthly CIP (Continuous improvement process) system review meeting.

    - Follow up tracking CIP project

    - Training for internal for using document, system…etc.

    · (20%)

    - Co-ordinate other department to implement CI & support project.

    - Other tasks assigned by LEAN Manager & Plant Director.

  • Skills & Competencies:

    · University degree majoring in office & administrative management, Industrial Engineering Engineer or Sciences etc.

    · At least 1-year experience at equivalent positions

    · Have experience or knowledge of ISO 9001

    · Having experience in the manufacture is a plus

    · Having experience in receiving a new project is an advantage.

    · Computer skills -- Excellent proficiency in MS office, Power BI, ERP system basic.

    · Proficiency in English

    · Strong communication skills.

    · Quick learner and high team work spirit.

    · Highly capable of identifying problems and problems solving

    · Positive, enthusiastic, creative, embrace changes, performs under pressure.

    KEY PERFORMANCE INDICATORS

    1. Document control (as ISO9001)

    2. Report weekly/monthly.

    3. Continuous improvement efficiency

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