Darian has experience with project management, cGMP working knowledge, and technical writing. She provides technical writing and quality oversight in support of commissioning, validation, SOPs, project reports, budgets, and protocol development. Darian has experience working with cross functional teams in construction management in the biopharma industry. Her experience includes procurement, tracking, budget reconciliation, project management, inventory control, and change order management.
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Maintains project dashboards, tracking deliverables and schedules
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Creates and updates Standard Operating Procedures for various clients.
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Supports the development/ revision of commissioning/ validation protocols (FAT, IQ, IOQ, OQ, PQ, and Validation Master Plan).
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Updates and maintains PTSI electronic library in support of technical writing projects for clients.
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Manages cGMP document library for PTSI project projects.
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Provides technical writing support for GMP Documentation.
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Ensures that documentation is complete, recorded, and compliant with cGMP regulations.
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Meets with clients, vendors, and PTSI SME’s in developing, revising, proofing SOP’s, validation protocols, and presentations.