Pravek Kalp Senior Marketing Executive Interview Questions and Answers for Freshers

Calibration of HPLC and column maintiance

Q1. Analytical method development
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Q2. Analytical method validation
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Q1. What is your current Package
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Q2. Where is your native place
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Q1. Personal and professional life experiences
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Q1. Job profile and working experience
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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?
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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.
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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?
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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?
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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?
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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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Q1. Tell me about current job responsibilities.
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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. What interests you about this role?
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Q2. I am excited about this role because it would provide me with the opportunity to apply the knowledge and skills I have gained in my studies to real- word problems
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Q1. Related to Good clinical practic
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Q2. BA BE guidelines for conducting studies
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Q1. Why you want change company
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Q2. What is the exposure area
Ans. 
Exposure area refers to the extent of an individual's experience or knowledge in a particular field or industry.
• Exposure area can be determined by analyzing an individual's education, work experience, and training.

• It is important for individuals to have a strong exposure area in order to excel in their chosen field.

• For example, a software engineer's exposure area may include programming languages, software development ...read more
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Q3. What is your strength in work area
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Q1. What is your current salary
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Q2. What is expected salary
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