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.

This is a 12 hours day shift role

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.

You will need to have:

• B.Sc. in Science/Engineering with a minimum of 3 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
• Minimum 3 years’ experience in a QA environment within the pharma industry or a related field.

• Strong knowledge of cGMP requirements for pharmaceutical manufacturing required.

• Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA or other authorities of similar standing.
• Excellent accuracy and attention to detail.
• Good knowledge of relevant computer packages e.g. Viva Vault  or similar.
• Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.
• Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
• Excellent time management organizational skills along with a proven ability to multi-task.

We would prefer for you to have:

• Experience of sterility assurance for drug substance and/or drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
• High level technical skills including auditing, pharmaceutical manufacturing and regulatory inspection management.
• Experience in CI also

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.