Tony.Moorcroft@CQ-Technology.com

+1  860-753-0179

Construction

  • Commissioning test document/protocol/procedure preparation -

    Develops and manages review and approvals.

    Engineering test documents comprising procedural steps to guide commissioning execution and provide documented evidence that equipment and systems operate per specification.

  • Qualification protocol preparation -

    Develops and manages review and approvals.

    cGMP documents comprising procedural steps to verify that (a) the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations and/or user requirements; (b) that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges; and (c) that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based.

  • Construction quality control -

    Oversees field activities and reviews documentation deliverables.

    Assures installed systems and equipment are compliant with quality plans and installation check documentation is per specification and meets good engineering/documentation practices.

  • Equipment and automation factory acceptance testing -

    Manages the workflow, supports testing activities and reviews documentation.

    Activities performed at the vendor’s factory/office to demonstrating that the equipment item and/or automation has been assembled/functions to specification and is ready to be shipped to the project work site.

  • Material receiving checks -

    Manages the workflow, performs checks, audits activities and checks documentation.

    An activity performed when equipment and materials are delivered to the work site to ensure damage has not occurred during shipment and the equipment and/or materials are per specification.

  • Installation Verifications -

    Manages the workflow, performs checks, audits activities and checks documentation.

    An activity performed when equipment and materials have been installed into work site to ensure compliance to specification, orientation and general arrangement.

  • Walkdowns, punch listing and mechanical completion sign off -

    Manages the workflow, participates and administers transfer of care custody and control from the construction team.

    A workflow process by which installed systems and equipment are inspected and deemed to be mechanically complete and safe to transition in to startup, shakedown and commissioning phase.

  • Documentation assembly and turnover -

    Manages the workflow, oversees documentation assembly and participates in documentation reviews and acceptance.

    An assembly of equipment vendor turnover documentation binders and construction field checkout documentation binders.

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Tony Moorcroft

avatar Tony brings to the table a blended strategy based on ASTM E 2500-07 (Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment) and the ISPE Commissioning and Qualification Baseline Guide - with a career exclusive in ... [Read More...]