Pharmaceutical Facilities/Utilities Validation SME

St Louis, MO

Job ID: 126904 Industry: Pharma

Pharmaceutical Facilities/Utilities Validation 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. As the project is progressing, they are looking to add two validation/qualification resources to complete gap assessments on a variety of equipment and systems.

 

Day-to-Day Responsibilities

 

The client is looking for a Validation SME with experience converting clinical sites into commercial solid dose manufacturing sites. This consultant will be performing a gap assessment for qualification of different equipment and systems. This consultant will be performing SOP review for Adequacy, LogBook Review, and Change Control Review. The bulk of the work will be focused around facilities and utilities validation. The main focus of the GAP Assessment would be the Glatt GPCG Pro5 Fluid Bed Processor and HVAC/Johnson Controls. The client wants one consultant that can focus on each of those areas. Some of the additional equipment they will be working with is as follows; Hach PAT700 TOC Meter, Compressed Air, Sweco, Glatt VG25 Granulator, Kramer Speedy Deduster, Portable Metal Check, Pharmatron MT50 (Set 7), Processor, MVP Blending System, Friabilator, Masterflex Pump. This will be a hands on technical role in a fast paced environment, the consultant needs to be able to hit the ground running.

 

Required:
  • GAP Assessment
  • Solid Oral Dosage
  • Equipment Qualification
  • Glatt GPCG Pro5 Fluid Bed Processor OR Johnson Controls/HVAC
  • SOP and Change Control Review

Job Type: Contract 

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