Quality Compliance Specialist, VAC-11982
Job Overview
As a Quality Compliance Specialist, your day will involve maintaining and improving key quality systems to ensure compliance with regulatory requirements. You will track and trend non-conformance reports (NCRs), oversee Corrective and Preventive Actions (CAPAs), and manage Annual Product Reviews (APRs). Your role includes assessing risk, providing actionable insights through metrics, and supporting management review processes. Success in this role requires analytical thinking, precision, and a proactive approach to problem-solving.
The ideal candidate for this position may have a background in pharmaceuticals, but individuals from diverse fields such as life sciences, engineering, business administration, or quality assurance are equally well-suited. Experience in regulatory affairs, process improvement, or operational quality systems will also be highly valuable.
Duties
- Monitor Quality Systems: Track NCRs, CAPAs, and complaints to identify trends and support continuous improvement initiatives.
- Risk Assessment: Evaluate risks associated with NCRs, escalate concerns as needed, and ensure timely resolution.
- Coordinate Annual Product Reviews: Schedule reviews, gather and analyse data, and route for approval in line with regulatory requirements.
- Generate Key Metrics: Prepare CAPA effectiveness reports and APR closure metrics to inform decision-making.
- Compliance Support: Assist with preparing materials for management reviews and ensure quality system deliverables are completed on schedule.
Requirements
Essential
- Bachelor’s degree in science or a Related Discipline: Preferably in pharmaceuticals, life sciences, engineering, or business administration.
- 2 Years of Relevant Experience: Proven ability to work within quality systems or compliance in a regulated industry.
- Regulatory Knowledge: Understanding of ICH guidelines, EU GMPs, US CFRs, and ISO standards.
- Analytical Skills: Capability to interpret and analyse data to provide actionable insights.
- Attention to Detail: Strong organizational skills and ability to handle detailed documentation and compliance metrics.
Desirable
- Experience in Quality Assurance: Prior experience in managing quality systems, CAPA processes, or similar roles in compliance.
- Regulatory Affairs Experience: Understanding of regulatory reporting and compliance processes in various industries.
- Technical Writing Ability: Proficiency in creating and reviewing regulatory or quality documentation.
Bonus
- Certifications in Process Improvement: Training or certifications such as Lean Six Sigma.
- Experience in a Compliance-Focused Role: Knowledge of quality council preparation or management review materials.
- Data Metrics Reporting: Hands-on experience in generating and interpreting metrics for quality improvement initiatives.
Application Process
To apply, submit your CV and a cover letter highlighting your relevant experience and how you meet the role’s requirements. Applicants must have the legal right to work in Ireland, and data submitted during the application process will be managed in compliance with GDPR and privacy regulations.
This role is ideal for detail-oriented individuals from diverse professional backgrounds who are passionate about quality systems and regulatory compliance. If you meet these criteria, we encourage you to apply.
