Data Integrity Specialist

St. Louis, MO

Industry: Pharmaceutical Job Number: 134722

 

Data Integrity Specialist

Environment:

Our client is a large Medical Device and Pharmaceutical manufacturer. They are in need of a Data Integrity specialist to ensure systems meet data integrity requirements. 

Responsibilities: 

 

This Data Integrity Quality and Compliance role will take direction from a Team Leader and/or Data Integrity Manager to support and enhance the quality and compliance operations with respect to Data Integrity. This includes assisting with ensuring systems meet data integrity requirements (ALCOA and 21 CFR Part 11).  This role may also assist with the authoring of solution development lifecycle documents (SDLC) including standard operating procedures, user requirements specifications, detailed design and configuration specifications, test plan, test cases, test strategy, change control, and decommissioning plans.  This role is also expected to assist in continuous quality systems improvement for the Quality Compliance department that interfaces between a set of local site combination product manufacturing quality standards.  Role will work on operations support (User Account Reviews, Periodic System Reviews, Change Controls) and projects support for these types of systems:  laboratory, manufacturing, environmental, quality support, configuration management.  

Required:

21 CFR Part 11, 211, 820

SDLC Documentation

Quality Systems Standards

5+ Years Pharmaceuticals

Job Type: Contract

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