Medsource Ozone Biomedicals Product Manager Interview Questions and Answers

Q1. What's your work experience and do you know life cycle management of us anda
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Q2. Have you handled site transfer projects
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Q1. Only salary negotiation try to get you in existing salary that's all
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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. Separation techniques for QC
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Separation techniques are used in quality control to separate and analyze different components of a sample.
• Separation techniques are used to isolate and identify individual components in a mixture or sample.

• Common separation techniques include chromatography, distillation, filtration, and centrifugation.

• Chromatography separates components based on their different affinities for a stationary phase and a mobile phase.

• Dis...read more
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Q2. Excellent experience through interview
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Q1. Experience and questions
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Q2. Experience in sales and business development
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QUestions on maths, sales experience and educatiom

Online psychometric test

Q1. Online psychology test
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Q1. General interview about the profile
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Q1. Factor affecting the lyophilization
Ans. 
Factors affecting lyophilization
• Temperature: The temperature during the lyophilization process affects the rate of sublimation and drying.

• Pressure: The pressure inside the lyophilizer chamber affects the rate of sublimation and drying.

• Product formulation: The composition and concentration of the product being lyophilized can impact the process.

• Freezing method: The method used to freeze the product prior to lyophilizati...read more
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Q2. What is the meaning of Triple point
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The triple point is the temperature and pressure at which all three phases of a substance (solid, liquid, and gas) coexist in equilibrium.
• The triple point is a unique combination of temperature and pressure for a substance.

• At the triple point, the solid, liquid, and gas phases of the substance can coexist in equilibrium.

• It is the point on a phase diagram where all three phases meet.

• The triple point is a fixed point use...read more
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Q3. Validation of lyophilizer
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Validation of lyophilizer involves testing and documentation to ensure its performance and reliability.
• Validation of lyophilizer is necessary to ensure that it consistently produces high-quality freeze-dried products.

• The process involves testing various parameters such as temperature, pressure, and drying time to ensure they meet predetermined specifications.

• Documentation of the validation process is crucial for regula...read more
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Q4. How to maintain HSO in lyophilized product
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Maintaining HSO in lyophilized product involves proper storage conditions and packaging.
• Store the lyophilized product in a cool and dry environment to prevent moisture absorption.

• Use appropriate packaging materials that provide a barrier against moisture and oxygen.

• Ensure the lyophilized product is sealed tightly to prevent any exposure to air.

• Consider using desiccants or moisture-absorbing packets in the packaging.

• Per...read more
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