QAV Specialist - Hybrid
A talented QAV Specialist is sought to support multiple capital projects at a state-of-the-art fill-finish facility and the company's first stand-alone vaccine and biologics plant outside the US.
Key Responsibilities:
* Provide quality oversight and direction for the introduction of new products.
* Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
* Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
Requirements:
* A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
* Quality oversight experience in reviewing and approving documents associated with Equipment Validation, Cleaning validation, Sterilization such as Autoclaves and other equipment like CTUs, Isolators, etc.
* Experience in Quality oversight of equipment Qualification and knowledge of how to review and approve the following documents: IQ, OQ, PQ, IOC, IOQ's, etc.
* Familiarity with systems such as KNEAT, IPI, Veeva Vault would be advantageous.
About the Opportunity:
This is a fantastic opportunity to work on a state-of-the-art facility and contribute to the success of a global pharmaceutical client.