THIS IS WHAT YOU WILL DO:

The QA Specialist(12 months fixed term) for the Bulk Drug Substance (BDS) and Drug Product (DP) facility at AAMF will be Responsible for delivery of quality assurance activities at the 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 medicinal product at AAMF. He/she is responsible for ensuring that manufacturing, testing, labeling, and storage of products 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.
• Review and approval of technical support documentation. (Examples include cleaning, process, method validation).
• Review and approval of functional area documentation (e.g. SOPs, Work Instructions, technical reports and protocols)
• Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
• Review and approve Validation protocols as required.
• Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
• Responsible for review and approval of Master Batch Records in accordance with Alexion’s internal procedures and GMP principles.
• Provide oversight of quality management system activities including Preventive Maintenance, Deviation and CAPA Management and Change Control Programs.
• Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
• Author, review and approve Quality Related Procedures as required.
• Support the Vendor/Supplier Management Program.
• Support the Raw Material Qualification Program.
• Develop and report quality metrics
• Oversee the effective documentation and tracking of quality management system activities including deviations, change control and CAPAs.
• Review and approve of Validation protocols as required.
• Perform day-to-day tasks, as well as assist with projects that support company objectives and continuous improvement initiatives.