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Phase III

Documentation Support:

  • Perform project closeout:

    • Check integrity and completeness of project documentation

    • Obtain and route Project Closeout Sign-off sheet

    • Archive all project documentation, including TOP

  • Other, as requested

All Phases

Administrative Support:

  • Support miscellaneous administrative tasks:

    • Distribute and route project documentation

    • Copy, print/plot, scan, fax, mail support

    • Document research support

    • Point-of-Contact for A/E and GC

  • Other, as requested

  • Allocate project support costs, like copy, mail, and time worked to the designated project sub-account(s)

  • Develop and update on quarterly basis the repro expenses report

Architectural / Engineering and General Contractor Consultants

The Architectural/Engineering and General Contractor Consultants are the persons contractually obligated to design and construct facilities or systems based on the project’s predefined scope. A/E and GC roles and responsibilities in the project support process are as follows:

Phase I

  • Establish relationship with Project Coordinator

    • Obtain from PM the name and contact info for the Project Coordinator

    • Identify the A/E documentation point-of-contact

  • Consult with the PC about documentation and project support procedures and requirements

  • If project is related to manufacturing or GMP areas, consult with the Manufacturing, Validation, Maintenance/Operations and other Amgen departments about their specific turnover documentation requirements, and understand these requirements

  • Participate in the design of project documentation flows

  • If feasible, establish the Project Reprographics Account with local vendor for processing the Drawings

Phase II

  • Comply with the project support documentation procedures and requirements, as well as any others related to the manufacturing, validation and maintenance/operations requirements

  • Deliver the project documentation to the PC for filing

  • Respond to any project correspondence in a timely manner

able continued on next page

Roles and Responsibilities

2-3

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