Pharmaceutical Quality Compliance SME

St. Louis, MO

Job ID: 125826 Industry: Pharma

 

Pharmaceutical Quality Compliance  SME

Project Description:

Our client is a large pharmaceutical company who is converting their clinical site into a commercial manufacturing site for a solid oral dosage product.

  Day to Day Responsibilities:

The client is looking for a quality compliance SME with experience converting clinical sites into manufacturing. The consultant will be looking at floor plans, equipment flow, and personnel to assess the SOPs and revise and edit as necessary.   The consultants should have experience with supplier quality and qualification. This consultant should have training experience for GMP QA and helping to critically solve gap assessments and issues that arise in a conversion program. The consultant must be a high energy person who will take the initiative and is comfortable doing the hands on technical writing as well. This will be the first steps in a large project initiative to convert this site. The consultant should have an understanding of qualification of solid dosage equipment as well as SOPs for facilities and utilities.

Required Skills:
  • Quality Training
  • Supplier Quality
  • Clincal-Commercial conversion
  • Quality Compliance
  • Gap Assessments
  • Solid oral dose

Job Type:Contract  

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