Zenvision Pharma Llp ADL Executive Interview Questions and Answers

Q1. How many ICH guidelines?, and it's topics
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Q2. Dissolution criteria for extended release drug
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Q3. ALCOA++ related questions
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Q4. Type of Audit trail?
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Audit trails are logs that track changes made to data, providing a record of who made the changes, when, and why.
• Audit trails are essential for maintaining data integrity and compliance with regulations.

• They help in identifying errors, fraud, or unauthorized access to data.

• Examples of audit trails include logs of user actions in a software system, changes made to a document, or modifications to a database.

• Audit trails ...read more
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Q5. What is the formula for calculating CU value or for AV
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The formula for calculating CU value or AV is based on the number of defects found during quality control inspections.
• CU value (Criticality Unit) is calculated by assigning a weight to each type of defect based on its impact on the product or process.

• AV (Acceptance Value) is calculated by summing up the CU values of all defects found during inspections.

• Formula: AV = Σ(CU value of all defects)

• Example: If a product has 3...read more
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Q6. What are the check points for dissolution test?
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Check points for dissolution test include equipment calibration, sample preparation, media selection, temperature control, and data analysis.
• Calibrate equipment regularly to ensure accurate results

• Properly prepare samples to ensure consistency

• Select appropriate media for dissolution based on drug solubility

• Maintain proper temperature control throughout the test

• Analyze data accurately to determine dissolution rate
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Q7. What is UCL and LCL? And how they calculated?
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UCL and LCL stand for Upper Control Limit and Lower Control Limit, respectively. They are statistical measures used in quality control to determine if a process is stable and in control.
• UCL is the highest value that a process can reach before it is considered out of control.

• LCL is the lowest value that a process can reach before it is considered out of control.

• UCL and LCL are typically calculated using statistical meth...read more
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Q8. If any extraneous peak observe in GC analysis, then how can you handle that?
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Extraneous peaks in GC analysis can be handled by identifying the source of contamination, adjusting parameters, and re-analyzing the sample.
• Identify the source of contamination by checking sample preparation, column condition, or instrument cleanliness.

• Adjust parameters such as temperature, flow rate, or injection volume to minimize extraneous peaks.

• Re-analyze the sample after making necessary adjustments to ensure ac...read more
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Q9. Which are the stability zones, and thier conditions?
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Q10. How to handle NQI and QI or decesion power to take incident or not?
Ans. 
Handling NQI and QI incidents requires thorough evaluation and decision-making based on established protocols.
• Thoroughly investigate the incident to determine if it falls under NQI (Non-Quality Incident) or QI (Quality Incident).

• Refer to established guidelines, protocols, and quality standards to assess the severity and impact of the incident.

• Consider the potential risks to patient safety, regulatory compliance, and ov...read more
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Q1. Why are you left your current organisation?
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Seeking new challenges and opportunities for growth.
• Desire for new challenges and opportunities for professional growth

• Looking for a more supportive work environment

• Seeking better work-life balance

• Company restructuring or downsizing

• Relocation to a different city or country
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Q2. How much rise you want?
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I am open to discussing a rise based on my qualifications, experience, and the responsibilities of the role.
• I am looking for a competitive salary that reflects my skills and experience.

• I am open to negotiation based on the responsibilities and expectations of the role.

• I would like to discuss the potential for performance-based bonuses or incentives.

• I am interested in opportunities for career growth and development with
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Q1. Tell me about your current organization
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Q2. Tell me about roles & responsibility of current organization
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Q3. Ready to relocate
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Q4. Ready to extend duty hours
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Q5. Challenges in current roles
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Q6. Experience in grievence handling
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I have extensive experience in handling grievances and resolving conflicts in an administrative role.
• I have successfully resolved employee grievances by actively listening to their concerns and addressing them promptly.

• I have implemented a grievance handling system that allows employees to submit their complaints anonymously, ensuring confidentiality.

• I have conducted thorough investigations into grievances, gathering a...read more
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Q1. Human Resources ROund
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Q2. Technical round
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Q1. Family background
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Q2. Qualification and previous experience
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Q1. Reason for switch
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Seeking new challenges and growth opportunities in a dynamic environment.
• Desire for professional growth and development

• Interest in exploring new challenges and opportunities

• Seeking a more dynamic work environment

• Wish to broaden skill set and knowledge

• Looking for a change in company culture or values
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Q2. Salary expectations
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Q1. Intoduction ,current postioning at work
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Q2. ASKS ME YOUR WEAK AREA
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Q3. Asks me your comanding area
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Gd was okay im they satisfied to me

Aptitude test is reasonable

Q1. What is DMF, modules in DMF, What is validation & different parameters of validation as per ICH Q2(R1)
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Q1. Basic questions regarding your previous job
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Core area general knowledge

Q1. Principles of operating instrument, Troubleshooting??
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Q2. QMS documents
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Q1. Salary ,benefits,
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Q2. General knowledge about job role
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