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. 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. 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?
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?
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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
Ans. 
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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Knowledge and work experience

Q1. Asked about previous experiences
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Q1. Process of aggregate in brief for all sections
Ans. 
Aggregate is the process of combining data from different sections into a single result.
• Aggregate functions are used to perform calculations on groups of rows to give a single result.

• Common aggregate functions include SUM, AVG, COUNT, MAX, and MIN.

• Aggregate queries often involve grouping data by certain criteria before applying the aggregate function.

• For example, calculating the total sales revenue by region or finding
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Q1. What is the notice period?
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The notice period is the amount of time an employee is required to give to their employer before resigning or terminating their employment.
• The notice period is typically stated in the employment contract or company policy.

• It is a formal way for employees to inform their employer about their intention to leave the job.

• The duration of the notice period can vary depending on the company and the employee's position.

• During ...read more
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Q2. Tell me about 21cfr part11
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