Sanofi Quality System Specialist Interview Questions, Process, and Tips

Q1. Guidelines for Quality Risk Management and the steps in Quality Risk Management
Ans. 
Quality risk management involves guidelines and steps to identify, assess, and mitigate risks in order to ensure quality in systems and processes.
• Guidelines for quality risk management include following regulatory requirements and industry standards

• Steps in quality risk management include risk identification, risk assessment, risk control, and risk review

• Risk identification involves identifying potential risks that may...read more
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Q2. Process explaining the proposal of risk mitigation and risk acceptance after attainment of residual risk
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After attaining residual risk, propose risk mitigation and acceptance process.
• Evaluate the residual risk and identify potential risk mitigation strategies

• Assess the feasibility and effectiveness of each strategy

• Prioritize the strategies based on their impact and feasibility

• Implement the selected strategies and monitor their effectiveness

• If residual risk is still present, determine if it is acceptable based on risk tole...read more
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Q3. How to communicate the risk factors to different stake holders and how to track the risk mitigation actions
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Risk factors can be communicated to stakeholders through clear and concise reports and meetings. Tracking can be done through regular updates and documentation.
• Create a risk assessment report that outlines the potential risks and their impact on the project or organization

• Schedule meetings with stakeholders to discuss the risks and potential mitigation strategies

• Provide regular updates on the progress of risk mitigatio...read more
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Case study wherein they looked on identifying the contributing factors of the new /existing risks, existing controls and calculation of severity, occurrence, detectability scoring for the identified risks, proposal of mitigation actions and tracking the same till closure or risk reduction achievement.

Q1. Process flow of QRM and personality test
Ans. 
QRM process flow involves identification, assessment, control, and review of risks. Personality tests help in identifying individual traits.
• QRM process flow includes identifying potential risks, assessing their impact, implementing control measures, and reviewing the effectiveness of the controls.

• Personality tests can be used to identify individual traits such as risk-taking behavior, attention to detail, and communica...read more
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