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Urgent requirement of Validation Engineer || Document Analyst (REMOTE) at Foster City, California, USA
Email: [email protected]
From:

Ayush Sharma,

HMG America

[email protected]

Reply to:   [email protected]

HMG America LLC is the best Business Solutions focused Information Technology Company with IT consulting and services, software and web development, staff augmentation and other professional services. One of our direct clients is looking for Document Analyst in Foster City, CA. Below is the detailed job description.

Title: Document Analyst 

Location: Foster City, CA - Remote ok

Duration: 6+ Months

Client: HCL America Inc.

Mandatory Skills: CSV, Validation skills

Job Description:

Job Requirements: 

Review the SAP S/4 HANA implementation lifecycle documents (Business Process Documents, Configuration Design Specification, Technical & Functional Design Specs) per the review checklist.

Review the test scripts for the requirements and test scenario coverage.

Review the executed test reports for the proper documentation of test results and evidences per the checklist.

Prepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and tested.

Review the defects for proper documentation per the checklist.

Ensure the documents impacted due to CR or defects are revised appropriately and approved in document management system as a part of release management process.

Support release management activities by reviewing and ensuring the pre-requisites are completed prior to the release.

Assist in preparation of Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materials.

Collaborate with the author of the documents and ensure that the review comments are addressed.

Maintain day to day activities status tracker and report routinely.

Perform Root Cause Analysis (as required) if the documents are found with reoccurring issues.

Follow good documentation practices throughout the process.

Skills: 

Experience with Software Development Lifecycle, Quality Management System and CSV is highly preferred.

Experience in using VeevaVault and reporting in VeevaVault is a plus

Excellent communication (oral and written) and attention to detail.

Skilled in MS Word for document creation, formatting and review 

Skilled in MS Excel functions for data analysis and reporting.

Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.

General knowledge of the pharmaceutical industry and associated regulatory expectations.

General knowledge of quality system requirements including document control and training management. 

Thanks & Regards

Ayush Sharma

IT Recruiter

HMG America LLC

Ph No.+1 732-790-5494

Keywords: sfour information technology computer associates
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Thu Dec 08 01:15:00 UTC 2022

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Location: Foster City, California