Ascential Technologies
Document Control
Ascential Technologies, Minneapolis, Minnesota, United States, 55400
GAMP
Coordinate and manage all GAMP project documentation deliverables.Maintain and update all GAMP document templates to ensure accuracy and process efficiency.Initiate all GAMP project procedural and verification documentation.Coordinate with subject matter experts to provide specific project-related content to applicable GAMP documents.Edit, final draft, and facilitate communications (internal/external) towards approval (electronic via RightSignature) and document completion.Project URS Response
Convert and develop selected customer specifications into URS Responses.Identify all documentation requirements and indicate as such in the Documentation column of the URS Response.Ongoing support of URS Response development for projects to be executed.Provide the accuracy critical for design and GAMP document development.Coordinate review and completion with stakeholders.TOP (Turn-Over-Package)
Create TOP Checklist Status document for each project.Gather TOP content from document owners and place in appropriate TOP sub-folders.Manage completion of all TOP content.Deliver TOP (folders & files) to the customer's designated Sharefile site.Other Responsibilities
Reviews final Project Proposals & URS Responses for project documentation deliverables. Tracks and communicates these deliverables with the Project Manager and project Engineers.RightSignature and ShareFile administration.Maintain and seek opportunities to improve engineering documentation systems.
Coordinate and manage all GAMP project documentation deliverables.Maintain and update all GAMP document templates to ensure accuracy and process efficiency.Initiate all GAMP project procedural and verification documentation.Coordinate with subject matter experts to provide specific project-related content to applicable GAMP documents.Edit, final draft, and facilitate communications (internal/external) towards approval (electronic via RightSignature) and document completion.Project URS Response
Convert and develop selected customer specifications into URS Responses.Identify all documentation requirements and indicate as such in the Documentation column of the URS Response.Ongoing support of URS Response development for projects to be executed.Provide the accuracy critical for design and GAMP document development.Coordinate review and completion with stakeholders.TOP (Turn-Over-Package)
Create TOP Checklist Status document for each project.Gather TOP content from document owners and place in appropriate TOP sub-folders.Manage completion of all TOP content.Deliver TOP (folders & files) to the customer's designated Sharefile site.Other Responsibilities
Reviews final Project Proposals & URS Responses for project documentation deliverables. Tracks and communicates these deliverables with the Project Manager and project Engineers.RightSignature and ShareFile administration.Maintain and seek opportunities to improve engineering documentation systems.