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.
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.
Document Analyst • San Mateo, CA, United States
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