10+ Trishul Engicon Interview Questions and Answers

I have extensive USFDA audit exposure and have implemented various compliance measures.

• I have been a part of multiple USFDA audits and have experience in handling them.

• I have implemented compliance measures such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).

• I have also ensured compliance with regulations such as 21 CFR Part 11 and 21 CFR Part 820.

• In my previous role, I led a team that successfully passed a USFDA audi...read more

Handled deviations during batch execution by identifying root cause, implementing corrective actions, and documenting the process.

• Identified root cause of deviation

• Implemented corrective actions to prevent future deviations

• Documented the deviation and corrective actions taken

• Communicated the deviation and corrective actions to relevant stakeholders

Regular maintenance, proper installation, and using high-quality components can reduce breakdown in machines.

• Regular maintenance can prevent wear and tear on machines

• Proper installation ensures that machines are set up correctly and reduces the risk of malfunctions

• Using high-quality components can increase the lifespan of machines and reduce the risk of breakdowns

• Implementing safety measures can prevent accidents that can damage machines

• Monitoring machines for signs of wear a...read more

CAPA stands for Corrective and Preventive Action. It is a process used to investigate and address complaints in the current market.

• CAPA is a systematic approach to identifying the root cause of a problem and taking corrective and preventive actions to prevent it from recurring.

• It involves investigating the complaint, identifying the cause, implementing corrective actions, and monitoring the effectiveness of those actions.

• Examples of CAPA include implementing new procedures, t...read more

Yes, I have drafted market complaint investigations.

• I have experience drafting market complaint investigations for various clients.

• I am familiar with the regulatory requirements and guidelines for such investigations.

• One example of a market complaint investigation I drafted involved a product recall due to safety concerns.

• I also worked on a market complaint investigation related to false advertising claims made by a competitor.

• My investigations have always been thorough and w...read more

OEE stands for Overall Equipment Effectiveness. It is a metric used to measure manufacturing productivity.

• OEE takes into account three factors: availability, performance, and quality.

• Availability measures the percentage of time the equipment is available for production.

• Performance measures the speed at which the equipment is running compared to its maximum speed.

• Quality measures the percentage of good quality products produced by the equipment.

• OEE is calculated by multiplying...read more

CAPA is effective in identifying and correcting root causes of problems to prevent recurrence.

• CAPA stands for Corrective and Preventive Action.

• It is a systematic approach to problem-solving and quality improvement.

• CAPA helps to identify the root cause of a problem and take corrective action to prevent recurrence.

• It also helps to prevent potential problems by taking preventive action.

• Effective CAPA implementation can lead to improved product quality, customer satisfaction, and...read more

I handle shift operations by ensuring proper communication, delegation of tasks, and monitoring performance.

• Maintain open communication with team members

• Delegate tasks based on individual strengths and workload

• Monitor performance and provide feedback for improvement

• Ensure proper handover between shifts

• Address any issues or concerns promptly

• Maintain a positive and productive work environment

Qualification stages can be categorized into three types.

• Theoretical qualification stage

• Practical qualification stage

• Final qualification stage

OSD stands for Oral Solid Dosage. It involves the breakdown and maintenance process of solid medications.

• OSD refers to solid medications like tablets and capsules.

• Breakdown process involves disintegration of the tablet or capsule in the gastrointestinal tract.

• Maintenance process ensures the stability and effectiveness of the medication.

• Examples include tablets that dissolve in the stomach to release the active ingredient.