Position Summary
The 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
Provide quality and cGMP input and oversight for all commercial manufacturing in the BDS facility.Review and approval of executed batch records in accordance with Alexion’s internal procedures and GMP principles.Review and approval of Master Batch Records in accordance with Alexion’s internal procedures and GMP principles.Review and approval of Master electronic Batch Record recipes in accordance with Alexion’s internal procedures and GMP principles.Review and approval of technical support documentation. (Examples include cleaning, process, method validation).Review and approval of functional area documentation (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.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.Provide oversight of quality management system activities including Preventive Maintenance, Deviation Management and the 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 Supplier Management Program.Complete review and releasing raw materials and components as required to support manufacturing operations.Develop and report quality metrics.Qualifications
English fluency written and spoken (the Company language).Strong verbal and written communication skills with well-structured communication and presentation ability.Ability to operate efficiently in a complex matrix organization and international environment.Minimum 3 years in pharmaceutical and/or biotech industry.Strong mature leadership and interpersonal influencing skills.Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.Education
Academic degree in natural or applied sciences (Pharmacy, Biology, Biotechnology or Engineering).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.