Description
Quality Assurance Deviations Writer and InvestigatorScope of Work:
As assigned by client quality management, contractor to provide quality assurance support associated with:
- Writing deviations
- Conducting investigations
- Conducting root cause analysis
- Identifying corrective and preventive actions (CAPAs)
- Developing CAPA action plans
- Writing investigations summary reports
- Providing on-the-manufacturing-floor quality input and decision-making support
- Writing and revising cGMP documentation, including SOPs and batch records
Contractor responsibilities are:
- Write, review, and/or edit deviations to ensure the event is clear, concise, complete, and meets Client quality requirements. Ensure any immediate actions taken to mitigate the effect of the deviation are documented.
- Conduct investigations thoroughly to identify all impacts to patients, product quality, validated state, and regulatory compliance.
- Conduct root cause analysis to identify all contributing and potentially contributing factors that led to the deviation.
- Perform risk analysis as needed to determine likelihood and severity of recurrence.
- Develop CAPAs and CAPA action plans.
- Write final investigation reports with focus on the following reviewers in mind:
o Client quality assurance
o Regulatory agencies
o Client customers
- Perform all technical writing with focus on clarity, conciseness, grammatical and mechanical correctness, accuracy, and completeness. Adhere to Client document styles and templates as applicable.
- Facilitate the investigation review and approval processes within applicable turnaround times or as needed to meet batch release timelines.
- Comply with Client quality requirements throughout investigations process.
- Be physically present in manufacturing areas during critical operations to:
o Facilitate real-time documentation review and good documentation practices
o Assist with determining and documenting deviations and process comments
o Assist with training manufacturing associates on quality impacts
- Provide general quality assurance and documentation support as requested