Pharmaceutical QA/Validation (Facilities/Utilities) SME

Austin, TX

Job ID: 125515 Industry: Pharma

 

Pharmaceutical QA/Validation (Facilities/Utilities) SME

Project Description:

Our client will be opening a new start-up manufacturing facility. They are looking for a QA generalist to help qualify equipment, utilities and the facility.

  Day to Day Responsibilities:

We are looking for a resource with strong Pharmaceutical experience, preferably also monoclonal antibodies experience. This person likely will have grew up in the validation area but should have transitioned more into a QA role/function. This person must have strong utilities, facilities and equipment experience. They should also have qualification and commissioning experience as they will actually help lead these efforts. Our client is a start-up, this individual should have prior start-up experience and need to be comfortable wearing multiple hats in a fast-paces environment.

They should have experience also performing and reviewing IQ, OQ and PQ’. They might also be asked to help improve their QMS – having this experience is also extremely helpful as well as Purified Water Systems

Required Skills:
  • Pharmaceutical
  • QA Compliance/Validation Oversight*
  • Facilities, utilities, equipment*
  • Monoclonal antibodies (highly preferred)
  • Start-up experience
  • Water Systems
  • Doc control management

Job Type: Contract 

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