- Provide technical writing support for operational functions, particularly Quality Control (QC).
- Author laboratory investigations for Out of Specification (OOS) events, deviations, CAPA, and change controls.
- Perform risk analysis to determine the severity and likelihood of recurrence during event triaging and investigations.
- Conduct thorough investigations for OOS events following FDA and Annex guidelines, identifying root causes and contributing factors.
- Assess impact on patients, product quality, data integrity, validated state, and regulatory compliance during investigations.
- Develop relevant and effective CAPAs, addressing impacts to systems, processes, products, and regulatory requirements when authoring change controls.
- Prioritize and monitor the completion of laboratory investigations, deviations, CAPAs, and change controls.
- Maintain concise and accurate technical writing standards, meeting established timelines.
- Generate and analyze relevant metrics for laboratory operations.
- Manage and author change controls related to equipment qualification, modification, and decommissioning.
- Possess and apply a strong understanding of data integrity principles.
- Ensure compliance with personnel training programs for operational functions.