QA Specialist (12 month fixed term contract)
Alexion Pharmaceuticals
Job DescriptionPosition SummaryThe QA Specialist for the Bulk Drug Substance (BDS) facility at ADMF will be responsible for providing oversight of quality activities associated with the manufacture and disposition of bulk drug substances at ADMF. The QA Specialist is responsible for ensuring that manufacturing, testing, labelling, and storage of Bulk Drug Substances comply with all applicable GMP regulations and the product authorizations’. This responsibility includes the oversight of the College Park 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 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 finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, QPs, Facilities, Engineering and Supply Chain to optimize patient supply. This position is a shift position, operating in extended days (7am-7pm, 4 days on, 4 days off).Principal Responsibilities
Qualifications
Education
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.
Dublin
Fri, 18 Apr 2025 22:59:48 GMT
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