Senior Technical Writer

• Mar 2022 - Present

Technical Writer

• Sep 2021 - Apr 2022

• Responsible to prepare Technical Documents like Release notes, Feature guides, Online help, Trouble shooting guides, Technical specification/System Requirements Specification,Installation Manuals,etc.• Collaboration with Project and other teams to get clear understanding of the product and the documentation requirements to prepare high quality documents that meets product standards.• Plan, Develop, Organize, Write and Edit content and make it easy for end user to utilize complex product/applications with simple and easy to understand language.• Information gathering from different teams and subject matter experts to write step by step procedures to prepare user manuals, technical specifications, and enhancements in the product.• Ensuring sharing the documents for verification with all stake holders regarding the observation need to take.• Responsible for product functionality verification with document.• Responsible to prepare user manuals, Technical Specification, and UI messages for application.• Meetings with SME’s & project managers regarding project clarification and queries related to the documentation. Show less

Technical Writer-Software-Validation & Documentation

• Jul 2018 - Aug 2021

• Responsible for software validation & verification with document. • Responsible to prepare test cases required for validation and to prepare validation documents like DQ, IQ, OQ,FAT & SAT document for machine & Software. •Collaboration with all SME’s and preparation of SRS document with the help of project managers as per the URS also preparation of FS,FDS, CS,Risk Assessment & Traceability matrix document. • Ensuring sharing the documents with all stake holders regarding the observation need to take, the follow-ups and regulatory compliance verification. • Responsible for preparation of standard template for project documents & review of all QA documentation like Impact Assessment & release notes ,change protocol documents. • Responsible to prepare user manuals, Technical Specification for Machine & software, on the basis of available data. • Responsible to ensure the verification of all BOM components with DQ, as per technical requirement of machine design and customer specification. • Meetings with SME’s & project managers regarding project clarification and queries related to the validation & documentation. • Direct interaction with customer to understand their requirements regarding, Pharma solutions, guidelines and hardware, software validation documents • Interaction with MALTA & USA team and customer regarding their clarification and queries related to the test case execution & software documentation • Factory acceptance test (FAT) along with customer for final trials in front of customer to answer the queries of customer regarding software & documents. Show less

Trainee Engineer– Validation & Documentation (QA)

• Jun 2017 - Jun 2018

• Conduct Factory Acceptance of the machines after offering from production. • Conduct factory acceptance along with customer for final trials in front of customer. • Responsible to ensure the verification of all BOM components as per technical requirement of machine design and software validation as per the customer specification. • Ensuring technical clarification with engineering drawing to the customer while their visit. • Cross functional meeting to get Discussing with the supplier for any input regarding process and quality. • Ensure sharing the IFAT report with all stake holders regarding the observation need to take the follow-ups and compliance verification. • Weekly meeting with France & USA team regarding their clarification and queries related to the documentation and parts. • Recording results and proposing improvement points to improve quality and machine functions. • Responsible to prepare IQ, OQ, DQ & PQ validation documents & to review CSV documents. Show less