Technical Writer
Current•Event Reporting accurately document events, incidents, or deviations as soon as they occur. Ensure that all relevant details are captured comprehensively, including the nature of the event, time and date, personnel involved, and initial observations.•Ensure that the documentation is clear, concise, and consistent with regulatory and company standards.•Work closely with various departments such as Quality Assurance (QA), Quality Control (QC), Production, and Regulatory Affairs to gather all necessary information regarding the event.•Conduct interviews with personnel involved in or witnessing the event to obtain detailed and accurate information. Participate in meetings to discuss the event and gather additional insights.•Compile data and evidence related to the event to support root cause analysis. This may include batch records, inspection reports, and equipment logs.•Assist in the root cause investigation by providing clear documentation that supports the identification of underlying issues.•Document proposed corrective and preventive actions (CAPA) resulting from the root cause analysis. Ensure that the CAPA plan is clearly articulated and includes timelines, responsible personnel, and expected outcomes.•Track the implementation of CAPA and document progress and completion. Ensure that records are updated and maintained throughout the process.•Coordinate the review process with relevant customers, ensuring that the documented event is thoroughly reviewed and approved by all required parties. •Facilitate the final sign-off of the event documentation by obtaining signatures from responsible authorities. Ensure that all sign-offs are documented accurately and stored in compliance with company policies.•Identify opportunities for improving the event documentation process. Implement changes to enhance efficiency, accuracy, and compliance.•Establish a feedback loop to learn from past events and improve future documentation and handling processes.
