Location
Inchicore, Dublin 8

Benefits
Healthcare, Pension, DIS x4 Salary + Hybrid Working

Company
My client are an Irish digital therapeutics company that develops products for managing injectable medications for patients in the home. The company’s injection care management system tracks adherence and persistence with medication schedules through the provision of medication management reminders, safe and sustainable sharps disposal devices, educational tools, and AI driven data analytics. The Company operates in seventeen markets globally and are headquartered in Dublin, with offices in Richmond, Virginia and Orlando, Florida

Role Overview
Support the Regulatory Affairs Manager in reviewing, implementing and assessing processes and procedures in accordance with GDPR legislation, ISO27001, EPA, and FDA, European and other regulatory requirements.

Responsibilities

Quality

• Maintain the eQMS, to support quality processes and compliance with regulatory and business requirements.
• Assist with maintaining Environmental Management System to maintain compliance with the HB EPA license conditions
• Support external inspections and audits by regulatory authorities or clients
• Investigate and document deviations, ensuring root cause analysis is thorough and accurate.
• Coordinate and oversee CAPA implementation and effectiveness checks.
• Collaborate with relevant stakeholders to implement the change control process as necessary
• Maintain documentation and records for change control activities.
• Conduct quality risk assessments for processes, products, and systems.
• Participate in the HB internal auditing process
• Support supplier management activities and ensure performance reviews are performed and documented
• Develop and deliver training for staff on quality processes
• Other activities as requested by the Regulatory Affairs Manager

• Provide reconciliation reports to clients on a monthly/quarterly/annual basis.
• Source Document Verification (SDV) and Quality Control Checks
• Carry out Quality Control checks as required
• Participate in PV audits
• Maintain and improve the pharmacovigilance system, including SOP updates and training.

• Bachelor’s degree in a scientific discipline or Relevant master's degree, desired

• Minimum 3 years’ experience in a quality or pharmacovigilance role
• Direct previous experience in the following is desired;
• Document control
• Conducting internal audits
• Conducting supplier audits/evaluations
• Investigating deviations
• Conducting RCAs
• Identifying and implementing CAPAs
• Developing and delivering training material
• Performing risk assessments
• Coordinating change controls
• AE reconciliations and SDV
• EPA licensing compliance

• Strong analytical and problem-solving abilities.
• Learn quickly and exhibit tech savviness
• Team player with high level of personal initiative; ability to prioritise effectively
• Strong written and verbal communication skills
• Foster a culture of openness, compliance, innovation and best practice