QA Specialist, GMP Packaging & Product Release

AstraZeneca; Dublin; On-site; EUR 70,000 - 110,000; Full time

Job summary

AstraZeneca in Ireland is seeking a Quality Assurance professional to oversee packaging activities, including NPI/Qualification for Finished Product, ensuring all testing, labeling, storage comply with QMS and cGMP standards. You will collaborate with Operations, QPs, Device Quality, External Quality, NPI, QC, Engineering and Supply Chain to optimise patient supply.

You will issue and review batch documentation, support QP release, lead investigations, and drive continuous improvements within

Qualifications

• Bachelor's degree in science, engineering or equivalent QA experience in international pharmaceutical and/or biotech industry with packaging experience a preference and advantage.
• 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.

Responsibilities

• Provide Quality oversight of packaging activities including NPI/Qualification for Finished Product Commercial and Clinical product at the College Park facility.
• Ensure testing, packaging, labeling, storage of Alexion products comply with QMS and all applicable regulations including cGMP Biopharmaceutical and Medical Device quality standards.
• Interact with Operations, QPs, Device Quality, External Quality, NPI, QC, Engineering and Supply Chain to optimise patient supply.
• Issue and review batch documentation, manage changes, complaints, deviations, and annual product quality reviews for College Park operations.
• Support the QP team in preparation and review of documentation for QP release.
• Provide Quality input and oversight for investigations to ensure robust root cause analysis and timely closure as per SOPs and QMS.
• Generate and report quality metrics.
• Review and approve functional area documentation (SOPs, PIs, Work Instructions, technical reports and protocols).
• Participate in quality risk assessments and maintain quality risk assessments.
• Author, review and approve QAGs.
• Lead investigation actions assigned to College Park from complaints processes.
• Support inspection readiness activities during health authority inspections and coordinate responses to observations.
• Support Quality Culture and continuous improvements at College Park.

Job description

AstraZeneca in Ireland is seeking a Quality Assurance professional to oversee packaging activities, including NPI/Qualification for Finished Product, ensuring all testing, labeling, storage comply with QMS and cGMP standards. You will collaborate with Operations, QPs, Device Quality, External Quality, NPI, QC, Engineering and Supply Chain to optimise patient supply.

You will issue and review batch documentation, support QP release, lead investigations, and drive continuous improvements within