Intas Pharmaceuticals Senior Executive QC Interview Questions, Process, and Tips

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

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

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

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

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

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

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

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