Quality Systems SME

Boston, MA

Job ID: 125374 Industry: Pharma

Quality Systems SME

Project Description:

Our client is a large pharmaceutical company who is looking for a Quality systems integration SME to assist with a large new facility project.

Day to Day Responsibilities:

The client is looking for someone to come on site and help them with their new facility expansion from a quality systems perspective. The consultant must have experience with facilities and utilities in a GMP regulated environment to help with gap assessments and quality systems integration. This person should be a hands on consultant who is self-motivated and will hit the ground running.  Consultant will need technical writing experience because he/she will be writing SOPs and performing GAP Analysis. It would be ideal if this person had a biologics as background.  They also may be doing commissioning work for the new facility.  This will be someone comfortable wearing multiple hats and will likely come from an operations background. They will be responsible for helping to integrate numerous policies and procedures, as well as writing them from scratch themselves.

Required Skills:

GMP experience is a must

Biologics

Pharmaceuticals

Gap Analysis

SOPs

Quality Systems

Job Type: Contract 

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