Are you interested in joining a world leading biopharmaceutical company, focused on developing advanced and innovative treatments for those suffering with rare diseases?
This is a fantastic opportunity to work in a state-of-the-art facility in Cork. You will be joining a leading Biopharmaceutical company who focus on a range of products which are life-changing for individuals.
Our client is currently seeking a QA Associate.
What You’ll Deliver
- Provide Quality direction and oversight of the start-up, technical transfer, operation, and continuous improvement of Sterile Drug Product Filling operations.
- Provide Quality input to Change Controls, Protocols and Reports ensuring scope of records are clear and implementation activities are robust and timely.
- Write, review and approve Standard Operating Procedures, Work Instructions, Quality Technical Agreements, Master Batch Records, Specifications and other GMP documentation in accordance with company policies.
- Participates within inter-departmental and cross-functional project teams to immediately address issues and questions in real time to help ensure project timelines are achieved.
- Degree or 3rd level qualification (Science, Quality). QP Qualification would be an advantage.
- Demonstrated experience in Sterile Drug Product Filling and start-up of same.
- Relevant experience working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role.
- Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems.