QAV SME

North Carolina

Long Term

Background:

Our client is a Pharmaceutical contract manufacturing organization that manufactures sterile injectables, tablets and capsules. They are seeking a strong QAV contractor with an aseptic processing background to support on-going capital projects at their North Carolina facility.

Project:

Our client is seeking a QAV SME to support capital projects on-site in North Carolina. They are currently working with sterile fill lines and need additional quality support for review and approval. On a day to day basis, this person will be responsible for review and approval of validation documents, including design qualification, commissioning, and review of IQ, OQ, PQ and other validation documents. This individual must come from a GMP Pharmaceutical background and must have experience working within an aseptic environment, specifically aseptic filling as well as sterility experience. While it is not required, it is a plus if this individual has prior experience qualifying lyos/or reviewing validation documents from lyos (lyophilizers).

Required:

• Pharmaceutical GMP
• QAV
• Sterility
• Design Qualification & Commissioning
• Aseptic Processing / Filling

Plus:

• Prior Lyophilizer Qualification Experience

karthik@itminds.net