Optimus Drugs Manager Interview Questions and Answers

Q1. Interviewer can ask as u mentioned your job responsibilities in your profile
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Q2. Tell me about your self
Ans. You can tell your educational background, family, positives etc.
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Q1. About 33kv single line diagram
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Q1. Basic questions like tell me about yourself etc
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Q1. Discussion with Business Development head
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Q1. With CBO discussion about business development
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Q1. Related to Lab work and LIMS
Ans. Explained all details about lab work and how it co-relate with LIMS
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Leadership and decision making skills.
Technical knowledge based on job profile.

Q1. Related to job profile questions
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Q2. Have good communication and presentation skills.
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Nice aptitude questions of logical reasons and data interpretation

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.
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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