Why Join?

- Competitive salary and comprehensive benefits package.

- Opportunity to work within a well-established, highly regulated manufacturing environment.

- Exposure to a broad range of regulatory, quality, and compliance activities across the product lifecycle.

- Cooperative culture with strong cross-functional engagement across Quality, Manufacturing, Technical Operations, and Supply Chain.

- Ongoing professional development and career progression opportunities.

- The chance to make a meaningful impact on product quality, regulatory compliance, and continuous improvement initiatives.

Key Responsibilities

Regulatory & Quality Operations

- Prepare and maintain regulatory documentation to support product registrations, variations, renewals, and responses to regulatory authority requests.

- Coordinate and review stability data and associated reports to support product lifecycle activities and regulatory submissions.

- Generate and maintain stability documentation and related reports using internal quality systems.

- Review and approve quality documentation, including product specifications, quality control documentation, certificates, and manufacturing records.





- Provide regulatory and compliance guidance to internal stakeholders regarding approved product documentation and quality requirements.

- Manage change control activities and assess the potential regulatory impact of proposed changes.

- Support the preparation and maintenance of site and product regulatory documentation.

- Assist with internal audits, quality system reviews, and continuous improvement initiatives.

- Participate in quality risk management activities and support regulatory compliance assessments.

- Review product documentation associated with manufacturing, packaging, and supply chain partners to ensure ongoing compliance.

- Support product quality review activities and contribute to periodic quality reporting requirements.

- Assist in the review and management of corrective and preventive actions (CAPAs) and related quality records.

- Participate in cross-functional meetings and provide regulatory and quality input to support business objectives.

- Support compliance with applicable regulatory requirements, industry standards, and company quality procedures.

📌 QA Regulatory Affairs Specialist (Leinster)
🏢 DPS Group Global
📍 Leinster