QA Specialist

This is what you will do:

The QA Specialist for the Bulk Drug Substance (BDS) facility at AAMF will be Responsible for delivery of quality assurance activities at the Drug Substance Athlone facility ensuring commercial and/or clinical products are manufactured in accordance with cGMP, Corporate and Regulatory requirements. This role will oversee quality activities associated with the manufacturing and disposition of bulk drug substances at AAMF. He/she is responsible for ensuring that manufacturing, testing, labeling, and storage of Bulk Drug Substances comply with all applicable regulations. This responsibility includes the oversight of the AAMF QMS to ensure that quality and compliance requirements are followed in line with business needs.

The QA Specialist executes the site QA activities at Alexion Athlone in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and approval. In particular, this will involve partnering with major stakeholders such as Operations, QC, Technical Services and Engineering to optimize patient supply.

You will be responsible for:

· Provide quality and cGMP input and oversight for all manufacturing activities for the Bulk Drug Substance facility.

· Re...

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