Finished-Product QA Specialist - GMP & Compliance

Alexion Pharma Spain S.L.; Blanchardstown; Remote; EUR 60,000 - 85,000; Full time

Job summary

Alexion seeks a QA Specialist – Finished Product at Blanchardstown Road North, Dublin, Ireland to provide Quality oversight of packaging for Finished Product for commercial and clinical products at the College Park facility.

You will interact with Operations, QPs, Device Quality, External Quality, NPI, QC, Engineering and Supply Chain to optimise patient supply and ensure GMP compliance in testing, packaging, labelling and storage in line with QMS and cGMP standards.

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

• 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 investigation 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

QA experience

Packaging

Education

Bachelor's degree in science, engineering or equivalent QA experience

Job description

Alexion seeks a QA Specialist – Finished Product at Blanchardstown Road North, Dublin, Ireland to provide Quality oversight of packaging for Finished Product for commercial and clinical products at the College Park facility.

You will interact with Operations, QPs, Device Quality, External Quality, NPI, QC, Engineering and Supply Chain to optimise patient supply and ensure GMP compliance in testing, packaging, labelling and storage in line with QMS and cGMP standards.