Pharmaceutical CSV SME

Marlboro, MA

Job ID: 128848 Industry: Pharma

 

Pharmaceutical CSV SME

 

Project Description:

 

Our client is a large pharmaceutical company who is implementing a new labeling and artwork management system. They need a high-level CSV consultant to come in and validate the system to Part 11 standards.  

 

Day-to-Day Responsibilities

 

The client is looking for a CSV consultant with experience validating a labeling and artwork management system.   This consultant will be validating electronic signatures, records, ERES records, for part 11 compliance. They will be responsible for authoring test scripts, validation documents, and validation master plans for the validation groups official approval. They will follow SDLC procedures and Gamp 5 while overseeing execution of OPQ’ s by the validation group. This consultant must have excellent writing and communication skills. They will start by getting up to speed on procedures, work flows, and test cases in a test environment, then moving over to the quality group where they will oversee execution of OPQ’ s.

 

Required:
  • CSV
  • Validation Master Plans
  • Author Test Scripts and Validation Documents
  • Trace Matrix
  • Part 11 Compliance
  • Gamp 5

 

Job Type: Contract

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