Our client is a large pharmaceutical company looking for someone who can perform Computer System Validation and equipment validation for a new production line they are installing. They need an experienced CSV Specialist for development and management of systems change controls and documentation.
The client is looking for a CSV consultant with experience writing SDLC documentation in accordance with local procedures, templates, and regulatory requirements. The regulatory requirements include 21 CFR Part 11, 211, and 820 as well as IT Security Standards.
This person will also be responsible for tracking and executing computer system periodic reviews, user account reviews, and other computer system compliance processes as assigned. They want this person to have excellent knowledge in writing a variety of validation documents including: validation master plans, validation protocols, associated SOP s, Part 11 risk assessments, and test scripts. This person will also be performing equipment validation on their new production line. The equipment will be for packaging, it will include new bottle/blister lines for their solid oral dosage facility.
Equipment Validation Experience
Author Test Scripts and Validation Documents
Part 11 Compliance
Job Type: Contract