Pharmalex Regulatory Affairs Manager Interview Questions and Answers

Q1. What projects have you handled?
Ans. 
I have handled various projects including implementing new sales strategies, launching new products, and improving customer service processes.
• Implemented new sales strategies to increase revenue by 15%

• Launched a new product line which resulted in a 20% increase in market share

• Improved customer service processes leading to a 30% decrease in customer complaints
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Q2. What challenges did you face while working on the project?
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I faced challenges with coordinating team members, managing tight deadlines, and adapting to unexpected changes.
• Coordinating team members with different schedules and priorities

• Managing tight deadlines and ensuring all tasks were completed on time

• Adapting to unexpected changes in project scope or requirements
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Q1. Tell me about yourself.
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Q2. What are your strengths and weaknesses?
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Q3. Where do you see yourself in 5 years?
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Q4. What are your salary expectations?
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Q5. What is your family background?
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Basic questions regarding the Regulatory affairs

Q1. Salary Package discussion
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Q1. Tell me about current job responsibilities.
Ans. 
Currently responsible for overseeing team performance, developing strategies, and ensuring project deadlines are met.
• Leading a team of 10 employees in project management

• Developing and implementing strategies to improve efficiency

• Monitoring progress and ensuring deadlines are met

• Collaborating with other departments to achieve company goals
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Q1. Tell me about yourself
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Q2. Why do you want to join Roche.
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Q1. How to prepare the QC laboratory for an Audit?
Ans. 
To prepare the QC laboratory for an audit, follow these steps:
• Ensure all equipment is calibrated and validated

• Review and update standard operating procedures (SOPs)

• Train laboratory personnel on audit procedures and expectations

• Perform internal audits to identify and address any non-compliance issues

• Organize and maintain documentation, including records of test results and equipment maintenance

• Implement a robust quality...read more
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Q2. What is an OOS investigation and one example?
Ans. 
An OOS investigation is a process to determine the cause of an out-of-specification result in a product or process.
• OOS stands for Out-of-Specification.

• It involves a thorough investigation to identify the root cause of the deviation.

• The investigation may include reviewing manufacturing records, conducting laboratory tests, and analyzing data.

• One example of an OOS investigation is when a pharmaceutical product fails to m...read more
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Q3. Explain about incident management process.
Ans. 
Incident management process involves identifying, responding to, and resolving incidents to minimize their impact on business operations.
• The process starts with incident identification, where incidents are reported or detected.

• Once an incident is identified, it is logged and categorized based on its severity and impact.

• A response team is then assigned to investigate and resolve the incident.

• During the investigation, th...read more
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Q4. Explain the calibration of HPLC?
Ans. 
Calibration of HPLC involves adjusting and verifying the accuracy and precision of the instrument.
• Calibration ensures that the HPLC system is performing accurately and reliably.

• It involves adjusting parameters such as flow rate, detector wavelength, and injection volume.

• Calibration standards of known concentration are used to verify the accuracy of the system.

• Precision is assessed by analyzing replicate injections of a...read more
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Q5. Discussion about guidlines ICH Q7, Q2 and Q1.
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Q6. What is a Validation and types of validation?
Ans. 
Validation is the process of checking if something meets certain criteria. Types of validation include data validation, form validation, and email validation.
• Validation is the process of ensuring that something meets specific requirements or standards.

• Data validation involves checking the accuracy, completeness, and consistency of data.

• Form validation ensures that user input in web forms is correct and meets specified ...read more
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Q7. How to fix the specification limit for an unknown impurity for an API?
Ans. 
To fix the specification limit for an unknown impurity in an API, conduct thorough analysis and consider regulatory guidelines.
• Perform comprehensive analysis of the impurity to determine its identity, properties, and potential risks

• Refer to regulatory guidelines and industry standards to establish acceptable limits for impurities

• Consider the impact of the impurity on the quality, safety, and efficacy of the API

• Collabor...read more
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Q8. Few Questions on instrument Calibration.
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