QA Specialist

This is what you will do:

Responsible for delivery of quality assurance activities at the Athlone Drug Product/Substance facility to ensure commercial and/or clinical products are manufactured in accordance with cGMP, Corporate and Regulatory requirements. This role will oversee the commercial and clinical manufacturing operations in the drug product/substance facility.

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:

• Site QA responsibility to provide technical expertise for all QA and compliance topics relating to Alexion manufacturing and product supply.
• Acts as quality point person, providing guidance and feedback on quality assurance issues.
• Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk
• Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Clinical and Commercial Operations groups.
• Provide sound QA and Compliance support to manufacturing, engineering, utilities, supply chain and material movement (including cold chain) for both clinical and commercial products.
• Ensure relevant QA documents and procedures are approved to schedule to support technology (external and internal) transfers and new product introductions.
• Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
• Deliver Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports as required.
• Actively contributes to continuous improvement activities.
• Provide support to Quality Control activities.
• Provide quality and cGMP support to the Drug Product/Substance operations where required.  

Qualifications

• A minimum of 3 years relevant experience within the pharma industry or a related field.
• Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required.
• Experience of sterility assurance for drug products/substance and in manufacturing processes for pharmaceutical products and processes strongly desirable.
• Direct experience of GMP management within a pharma/biopharma company is crucial, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing. 
• Excellent accuracy and attention to detail
• Good knowledge of relevant computer packages e.g. Trackwise or similar
• Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.
• High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required.
• Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
• The individual in this position is expected to represent Alexion Pharmaceutical interests, objectives and policies in a responsible and professional manner.       

Education

• Third level qualification e.g. B.Sc. in science/pharmacy with a minimum of 3 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.

Competencies

• Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.

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.