Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

This is what you will do:

Responsible for delivery of quality assurance activities at the Athlone Drug Product 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 sterile filling 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?issued 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 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 and in manufacturing processes for pharmaceutical products and processes strongly desirable.
• Direct experience of GMP management within a pharma/biopharma company is essential, 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.

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.