Job Description

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- Competitive salary and comprehensive benefits package.
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- Opportunity to work within a well-established, highly regulated manufacturing environment.
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- Exposure to a broad range of regulatory, quality, and compliance activities across the product lifecycle.
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- Collaborative culture with strong cross-functional engagement across Quality, Manufacturing, Technical Operations, and Supply Chain.
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- Ongoing professional development and career progression opportunities.
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- The chance to make a meaningful impact on product quality, regulatory compliance, and continuous improvement initiatives.
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Why Join? nn
- Competitive salary and comprehensive perks package.
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- Opportunity to work within a well-established, highly regulated manufacturing environment.
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- Exposure to a broad range of regulatory, quality, and compliance activities across the product lifecycle.
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- Collaborative culture with strong cross-functional engagement across Quality, Manufacturing, Technical Operations, and Supply Chain.
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- Ongoing professional development and career progression opportunities.
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- The chance to make a meaningful impact on product quality, regulatory compliance, and continuous improvement initiatives.
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Key Responsibilities Regulatory & Quality Operations nn
- Prepare and maintain regulatory documentation to support product registrations, variations, renewals, and responses to regulatory authority requests.
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- Coordinate and review stability data and associated reports to support product lifecycle activities and regulatory submissions.
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- Generate and maintain stability documentation and related reports using internal quality systems.
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- Review and approve quality documentation, including product specifications, quality control documentation, certificates, and manufacturing records.
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- Provide regulatory and compliance guidance to internal stakeholders regarding approved product documentation and quality requirements.
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- Manage change control activities and assess the potential regulatory impact of proposed changes.
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- Support the preparation and maintenance of site and product regulatory documentation.
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- Assist with internal audits, quality system reviews, and continuous improvement initiatives.
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- Participate in quality risk management activities and support regulatory compliance assessments.
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- Review product documentation associated with manufacturing, packaging, and supply chain partners to ensure ongoing compliance.
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- Support product quality review activities and contribute to periodic quality reporting requirements.
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- Assist in the review and management of corrective and preventive actions (CAPAs) and related quality records.
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- Participate in cross-functional meetings and provide regulatory and quality input to support business objectives.
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- Support compliance with applicable regulatory requirements, industry standards, and company quality procedures.
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📌 QA Regulatory Affairs Specialist (Leinster)
🏢 DPS Group Global
📍 Leinster