QAV Specialist - (Hybrid) 2/3 days per week
Carlow - 11-Months
With worldwide demand for their life-changing oncology treatment increasing, one of our global pharmaceutical clients is looking for a QAV Specialist to join their team to support multiple capital projects taking place onsite in Carlow.
This 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.
Role Summary
1. Provide quality oversight and direction for the introduction of new products.
2. Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
3. Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
Requirements
1. A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
2. 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.
3. Experience in Quality oversight of equipment Qualification and knowledge of how to review and approve the following documents: IQ, OQ, PQ, IOC, IOQs, etc.
4. Familiarity with systems such as KNEAT, IPI, Veeva Vault is also desirable.
If you are interested, please apply now for immediate consideration and further information.
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