Apply Now Quality Assurance Analyst

6 days ago

Dublin, Ireland Independent Solutions Full time

Role Overview The Quality Assurance Specialist will play a crucial role in ensuring compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements in a dynamic pharmaceutical manufacturing environment. The role requires providing QA support to production teams, conducting batch documentation reviews, and supporting audit readiness, with a focus on sterile manufacturing processes.
Key Responsibilities Work within a 4-shift pattern role , supporting manufacturing operations on-site.
Provide QA support to production teams , ensuring adherence to cGMP and quality standards.
Conduct timely reviews of batch documentation (EBRs) , line clearances, investigations, and reports, resolving concerns based on risk assessment.
Support audits, inspections, and spot checks/walk-throughs of production areas to maintain audit readiness and compliance.
Respond quickly to unplanned events and technical issues in manufacturing.
Ensure continuous improvement of quality systems , tracking metrics such as right-first-time documentation and compliance KPIs.
Engage in customer complaint investigations , deviations, and CAPA processes as required.
Utilize quality systems (SAP, TrackWise, MES) to manage and document QA activities.
Maintain a strong understanding of cGMP, GDP, US and EU regulatory requirements .
Promote a culture of compliance, safety, and audit readiness across the site.
Qualifications & Experience Bachelor’s degree (Science discipline preferred) .
2-3 years’ experience in a quality role within a pharmaceutical manufacturing facility, preferably aseptic/sterile operations.
Demonstrated knowledge of cGMP, GDP, US and EU regulatory requirements .
Experience with SAP, MES, TrackWise (or equivalent QA/ERP/QMS systems) is desirable.
Strong skills in report writing, standards interpretation, and technical documentation .
Ability to prioritize multiple tasks, manage time effectively, and meet strict deadlines .
Flexible to work shift-based schedules .
Specialized Skills Batch Record Review (EBR/BMR), Line Clearance
Deviations, CAPA & Change Control (TrackWise, SAP, MES, EDMS)
cGMP, GDP, Data Integrity (ALCOA+)
Audit Readiness & Regulatory Compliance (FDA, EMA, EU GMP Annex 1)
Sterile / Aseptic Manufacturing QA Support

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