RAKS Pharma ADL Executive Interview Questions and Answers

SWOT ANALYSIS OF A NEW PRODUCT IN THE MARKET

RESEARCH ASSIGNMENT ON THE TB SPACE

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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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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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. What is organic chemistry, wt is ph, what is tlc, what is polar non polar solvents, how to prepare 1N hcl,1NnaoH, formulas of Acidsetc
Ans. 
Organic chemistry is the study of carbon-based compounds. pH measures acidity or alkalinity. TLC is a technique for separating compounds.
• Organic chemistry focuses on the study of carbon-containing compounds.

• pH is a measure of the acidity or alkalinity of a solution.

• TLC (Thin Layer Chromatography) is a technique used to separate and analyze compounds in a mixture.

• Polar solvents dissolve polar compounds, while non-polar ...read more
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Q2. Chemical name of AA, chemical structures , named reactions like grignald reaction
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AA is a common abbreviation for amino acids. They have a general structure of NH2-CHR-COOH and can undergo various named reactions like Grignard reaction.
• AA stands for amino acids which are the building blocks of proteins

• Their general structure is NH2-CHR-COOH where R can be any of the 20 different side chains

• Grignard reaction is a named reaction used to form carbon-carbon bonds and is commonly used in organic synthesi
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Q3. Densitys of solvents
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Density of solvents is an important property for various chemical processes.
• Density is the mass per unit volume of a substance.

• Solvents with higher density can dissolve more solutes.

• Density can be affected by temperature and pressure.

• Examples of solvents with different densities include water (1 g/mL), ethanol (0.789 g/mL), and chloroform (1.48 g/mL).
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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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