CSV | Remediation Transition Validation & Compliance Project Management Project
About this Project OBJECTIVE Validation and compliance project for the transition of computerized systems from the previous system SERVICES…
Regulatory Affairs | Strategy Support Projects
PSC® continues to support the Global Regulatory Affairs division for a large biopharmaceutical company, focused on plasma-derived therapies for rare and complex diseases. This company’s headquarters is in Cambridge, MA, but we support locations in the Greater Atlanta region and Greater Los Angeles region.
Extensive Technical Writing & Validation Execution
PSC® performed technical writing support for 3 months utilizing a Senior Technical Writer. The project started on 6/10/2020 and concluded on 9/10/2020 or agreed upon timeframe. PSC® provided project schedule oversight through the entire project.
Technical Writing | Conducting Investigations & Resolving Nonconformance’s
Provided technical writing services. The scope of technical writing to be provided included: Lot release- was actually researching errors and inconsistencies in existing records. Also generated SOP’s for equipment facilities and utilities.
Technical Writing | Researching Errors & Inconsistencies In Existing Records
PSC‘s® technical writer for this project primarily wrote, edited, and reviewed cGMP documents, Systems Specifications, SOPs, and related materials while maintaining standardized documentation practices for recording details of new processes.
Technical Writing | Engineering Projects & New Equipment Implementation
PSC provided the Texas facility with technical writing support for engineering projects and new equipment implementation. Documents included Functional Risk Assessment, System Risk Assessment, Standard Operating Procedures, Work Instructions, Traceability Matrix, User Requirement Specifications, and Functional Requirement Specifications.
