Support Operations Quality Notifications and Investigations Specialist
CR/078833
Posted: 20/08/2025
- Competitive
- Ireland, County Meath, Dunboyne
- Contract
Orion Group Life Sciences are currently recruiting a Support Operations Quality Notifications and Investigations Specialist on behalf of our Multinational Biopharmaceutical Client based in Meath on an initial 11-Month contract with potential to extend.
Responsibilities:
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Responsibilities:
- Author Quality Notifications: Take full ownership of drafting, reviewing, and finalizing Quality Notifications, ensuring clarity, accuracy, and compliance with regulatory requirements Initiate and maintain quality related metrics related to Quality Notifications ensuring effective communication and follow up of the same.
- Quality Metrics: Ensure that Quality notifications (including CAPAs, Investigations and incidents) meet our metrics for raised on time and closed on time, while maintaining a high standard of technical writing and compliance.
- Incident Reporting: Solely manage the authoring of incident reports, documenting quality issues and ensuring timely submission for review and approval.
- Investigations Documentation: Lead the authoring of comprehensive investigation reports, detailing findings, root cause analyses, and corrective actions.
- Approval Process Management: Navigate the approval process for all authored documents, collaborating with cross-functional teams to ensure timely reviews and compliance with quality management systems.
- Quality Risk Assessments: Participate in Quality Risk Assessments as needed, providing insights and documentation to support the evaluation of quality risks.
- Continuous Improvement: Contribute to a culture of continuous improvement by identifying opportunities for enhancing documentation processes and quality practices.
- Compliance Adherence: Ensure all authored documents meet the necessary compliance standards and are aligned with the Manufacturing Division Quality Management Systems (QMS).
- Training and Support: Provide guidance to team members on best practices for documentation and compliance, fostering a culture of quality awareness
- Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
- 2 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components). Position level will scale with experience level of candidate.
- Strong technical writing capability and previous experience authoring reports and investigations in a GMP environment
- Competent in analysing complex situations and show practical problem-solving capabilities.
- Understanding of Upstream and Downstream Unit Operations for mAb manufacturing
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Aoibhinn Daly
Recruitment Consultant
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