What are the responsibilities and job description for the Project Manager - L3 position at Alpha Numeric?
Alphanumeric is hiring a PROJECT MANAGER - Level 3 to work in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.
Scope of position :
Periodic Review of 34 Commercial Off The Shelf (COTS) systems
Summer Mapping of the GMP warehouse
Winter Mapping of the GMP Warehouse
Decommissioning of Legacy Environmental Monitoring System (Hanwell)
Asset Introduction and Validation of Wireless Data Logger software and probes (ellab)
Job Requirements
Roles / Responsibilities :
Validation PM
Track spend against deliverables.
Develop and maintain Validation dashboard.
Adjust resources based on demands.
Manage Day to Day.
Coordinate with fellow Validation leads.
Generate and reconcile Invoices.
Develop Project Schedule.
Additional responsibilities / skills that could fall under this scope :
Update the Computerized Systems Validation Master Plan
Provide Validation Assessments for any change controls linked to systems.
Develop validation protocols in support of any change controls.
Execute Validation protocols related to change controls.
Close / Update Change Control tasks assigned to Validation.
Reviewer / approver of completed periodic reviews.
Oversee / Support the Validation of the Wireless data loggers used for temperature mapping.
Develop and execute the Validation IOPQ for the wireless data loggers.
Oversee the development, revision, and approval of System Risk Assessments, Design Qualifications, Functional and Configuration Specifications, System Classifications, etc.,.
Support the role out of the Kneat system at the Binney Street site.
Reviewing and revising as needed Validation procedures specific to Computerized Systems Validation which include periodic review of the procedures.
Act as a backup for Spreadsheet Validation
Decommissioning of the Hanwell EMS System
Maintain the Site Validation Master Plan
Provide Validation Assessments for any change controls linked to equipment, facilities, utilities.
Develop validation protocols in support of any equipment, facilities, and utilities related change control.
Execute Validation protocols related to change controls.
Execute periodic reviews (31-34 systems)
Update the Periodic Review and Requalification schedule as periodic reviews as applicable.
Oversee, shadow, and approve vendor execution related to equipment modifications.
Develop, execute and approve wrapper protocols.
Support seasonal mapping (winter and summer) of the GMP Warehouse
Reviewing and revising as needed procedures specific to commissioning and Qualification which include periodic review of the procedures.
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