Quality Assurance Specialist

3 days ago


Dublin, Dublin City, Ireland Life Science Recruitment Ltd Full time
Company Overview
In the life sciences industry, our client is a digital therapeutics company that develops innovative solutions for managing injectable medications. Their injection care management system ensures adherence and persistence with medication schedules through reminders, sharps disposal devices, educational tools, and AI-driven analytics.

The company operates globally in seventeen markets, with headquarters in Dublin and offices in Richmond, Virginia, and Orlando, Florida.

Salary and Benefits
A competitive salary package includes healthcare, pension, and hybrid working arrangements.

Job Description
As a Quality Assurance Specialist, you will support the Regulatory Affairs Manager in reviewing, implementing, and assessing processes and procedures according to GDPR legislation, ISO 27001, EPA, and FDA requirements.

Responsibilities:
1. Maintain the eQMS to ensure quality processes and compliance with regulatory and business requirements.
2. Assist with maintaining the Environmental Management System to meet HB EPA license conditions.
3. Support external inspections and audits by regulatory authorities or clients.
4. Investigate and document deviations, ensuring thorough root cause analysis.
5. Coordinate and oversee CAPA implementation and effectiveness checks.
6. Collaborate with stakeholders to implement change control processes as necessary.
7. Conduct quality risk assessments for processes, products, and systems.
8. Participate in internal auditing processes and supplier management activities.
9. Develop and deliver training on quality processes.

Pharmacovigilance (PV) Responsibilities
1. Provide reconciliation reports to clients on a monthly/quarterly/annual basis.
2. Source Document Verification (SDV) and Quality Control Checks.
3. Participate in PV audits and maintain/improve the pharmacovigilance system.

Qualifications
A Bachelor's degree in a scientific discipline or relevant master's degree is desired. Minimum 3 years of experience in a quality or pharmacovigilance role is required.

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