QAV Specialist - (Hybrid) 2/3 days per week
With growing demand for their life-changing oncology treatment, our global pharmaceutical client is seeking a QAV Specialist to support multiple capital projects in Carlow.
Role Overview:
* 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.
Key Responsibilities:
Quality Oversight:
1. Review and approve documents associated with Equipment Validation, Cleaning validation, and Sterilization such as Autoclaves and other equipment like CTUs, Isolators, etc.
2. Quality oversight of equipment Qualification and knowledge of how to review and approve the following documents: IQ, OQ, PQ, IOC, IOQs, etc.
Experience Requirements:
* A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
* Familiarity with systems such as KNEAT, IPI, and Veeva Vault is advantageous.
About Us:
This is an opportunity to work on a state-of-the-art fill-finish facility and the company's first stand-alone vaccine and biologics plant outside the US.