QA Specialist, Packaging & NPI Quality Oversight

AstraZeneca plc; Dublin; Remote; EUR 90,000 - 130,000; Full time

Job summary

AstraZeneca plc in Ireland is seeking a Quality leader responsible for providing Quality oversight of packaging activities including NPI/Qualification for Finished Product Commercial and Clinical product at the College Park facility. Ensuring testing, packaging, labelling, storage comply with QMS and cGMP quality standards.

This role ensures effective interaction with departments and locations regarding GMP document review and finished product release, partnering with Operations, QPs, Device

Qualifications

• Bachelor's degree in science, engineering or equivalent QA experience in international pharma/biotech.
• Strong knowledge of GMP, QMS and regulatory requirements for pharmaceutical products.
• Ability to prioritize daily activities in a fast-paced environment and collaborate across functions.
• Excellent communication and stakeholder management skills.

Responsibilities

• 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 investigtion 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 actions.
• Support the drive of Quality Culture and support implementation of continuous improvements at College Park.

Skills

Quality Assurance

GMP compliance

QMS

Packaging

Regulatory understanding

Education

Bachelor's degree in science

Job description

AstraZeneca plc in Ireland is seeking a Quality leader responsible for providing Quality oversight of packaging activities including NPI/Qualification for Finished Product Commercial and Clinical product at the College Park facility. Ensuring testing, packaging, labelling, storage comply with QMS and cGMP quality standards.

This role ensures effective interaction with departments and locations regarding GMP document review and finished product release, partnering with Operations, QPs, Device