QAV Specialist - Hybrid
This role is a fantastic 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.
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, and Sterilization such as Autoclaves and other equipment like CTUs, Isolators, etc.
* Experience with Quality oversight of equipment Qualification and knowledge of how to review and approve the following documents: IQ, OQ, PQ, IOC, IOQs, etc.
* Familiarity with systems such as KNEAT, IPI, and Veeva Vault is also advantageous.
We are seeking a highly skilled QAV Specialist to support multiple capital projects taking place onsite in Carlow. This is an exciting opportunity to work in a dynamic environment and contribute to the success of our client's life-changing oncology treatment.