This is what you will do:
The QA Specialist for Quality Operations will be responsible, with management support, for providing oversight of quality activities associated with documentation of the Finished Product packaging activities for commercial and clinical product at the College Park facility. He/she is responsible for ensuring that testing, packaging, labelling, storage of Alexion products comply with QMS and all applicable regulations.
You will be responsible for:
- Perform issuance and review of batch documentation, management of changes, complaints, deviations, and annual product quality reviews related to College Park operations.
- Support the QP team, in relation to preparation and review of the relevant documentation for QP release
- Provide Quality input, oversight and guidance to Alexion deviations and investigations to ensure robust root cause analysis/CAPA definition and timely closure as per Alexion SOPs and QMS.
- Generation and reporting of quality metrics
- Review and approval of functional area documentation (SOPs, PIs , Work Instructions, technical reports and protocols)
- Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
- Author, Review and Approval of QAGs
- Leading actions assigned to College Park from complaints process
- 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
You will need to have:
- Bachelor's degree in science, engineering or equivalent
- 5+ years QA experience in international pharmaceutical and/or biotech industry with packaging experience a preference
- Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements
- Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment
- Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization
- Strong verbal and written communication skills with well-structured communication and presentation ability.
We would prefer for you to have
- Efficient in SAP, Veeva Vault and Trackwise.
- Demonstrated success in improvement processes
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.