Friday, February 24, 2023 at 11:47:31 AM Japan Standard Time
India, Gujarat, Gandhinagar

  • Full-time
  • 11-50 employees
  • About the job

    · Creating and Reviewing Validation Documents in accordance with Company Policies and Procedure.

    · Creating and reviewing DQ/IQ/OQ Paper Format.

    · Developed SOPs for Change Control System.

    · Crating Documents like Risk Assessment, CAPA, Impact Assessment, Trouble Shooting, FAT, FRS and User Manual as per 21 CFR Part 11 and GAMP 5.

    · Validated Qualification Documentation as per SOP · Creating Test Cases in Qualification Documentation

    · Writes and edits technical documents including reference manuals and product manuals.

    · Writes and edits procedural documentation such as user guides and manuals.

    · Determines the type of publication that will best serve the project requirements.

    · Meets with engineers, programmers, and project managers to learn about specific products or processes.

    · Researches product samples to fully understand product.

    · Assesses the audience needs for whom the technical and procedural documentation is intended; adjusts tone and technical terms used to meet those needs and to ensure understanding.

    · Plans writing processes and sets timelines and deadlines.

    · Creates or works with graphic designers to create diagrams, charts, and other visual aids to assist readers in understanding a product or process.

    · Gathers feedback from customers, designers, and manufacturers to improve technical documents.

    · Performs other related duties as assigned.