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.