Our client, a global bio/pharmaceutical leader, is seeking an experienced QA Specialist to join their team in Dublin City Centre. You will be responsible for writing and investigating product quality complaints and all related activities associated with the complaint handling program.
Duties and responsibilities of the QA Specialist will include but are not limited to:
- Initiating, writing and managing the complaint investigation to completion.
- Serve as point of contact for commercial product complaints and post market product vigilant monitoring processes.
- Receive, initiate, investigate and conclude product complaint investigations using the current product complaints management mailbox and software.
- Coordinate all aspects of investigation through to closure and/or provide oversight for complaint handling process.
- Apply departmental procedures to assess product complaints' impact on patient safety and product quality compliance.
- Assess product complaints and determine if escalation is required due to potential regulatory notification requirements.
- Send customer response letters where required.
- Support the departmental complaint management process through attendance of meetings to ensure on time closure of complaints.
- Support line manager to meet business needs.
You will have skills and experience in the following:
- BSc with a minimum of 3-5 years QA experience in pharma/bio organisation.
- SME in assigned product platform (Small Molecule & Oncology) and a strong working knowledge of the complaints process or multiple pharmaceutical quality management systems.
- Knowledge of EU/ FDA cGMP requirements pertaining to drug/device product complaints reporting and investigation.
- Desirable experiences: combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits.
- Skill in writing investigation summaries or reports and complaint responses.
- Strong attention to detail, good organizational skills and well-structured.
- Ability to work independently as well be an effective team member and leader.
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.