Quality Notifications and Investigations Specialist

4 weeks ago

Dunboyne, Meath, Ireland Tandem Project Management Ltd. Full time
Summary:
A Quality Notifications and Investigations Specialist is required for a biopharmaceutical company in Dunboyne.
The successful candidate will provide operational support for manufacturing operations onsite. This role is fully based onsite.

Responsibilities:

- 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.
- 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.
- Solely manage the authoring of incident reports, documenting quality issues and ensuring timely submission for review and approval.
- Lead the authoring of comprehensive investigation reports, detailing findings, root cause analyses, and corrective actions.
- Navigate the approval process for all authored documents, collaborating with cross-functional teams to ensure timely reviews and compliance with quality management systems.
- Participate in Quality Risk Assessments as needed, providing insights and documentation to support the evaluation of quality risks.
- Contribute to a culture of continuous improvement by identifying opportunities for enhancing documentation processes and quality practices.
- Ensure all authored documents meet the necessary compliance standards and are aligned with the Manufacturing Division Quality Management Systems (QMS).
- Provide guidance to team members on best practices for documentation and compliance, fostering a culture of quality awareness.

Qualifications & Experience:

- Bachelor's degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
- 2 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components).
- 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.
- Experience in leading and facilitating Root Cause Analysis and Quality Risk Assessment sessions
- Experience supporting Regulatory Inspections and Site Internal Audits.
- Understanding of Upstream and Downstream Unit Operations for mAb manufacturing.

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