Intas Pharmaceuticals Assistant Manager Regulatory Affairs Interview Questions and Answers

I am seeking new opportunities to grow professionally and expand my skill set.

• Looking for a company that values continuous learning and development

• Seeking a more challenging and dynamic work environment

• Want to work with a team that promotes collaboration and innovation

• Desire to explore new technologies and methodologies

• Seeking better career growth prospects and opportunities for advancement

I have 5 years of experience as a Quality Analyst.

• I have worked in various industries, including software development and manufacturing.

• I am proficient in using quality assurance tools and techniques.

• I have experience in conducting quality audits and inspections.

• I have successfully implemented quality improvement initiatives.

• I have strong analytical and problem-solving skills.

• I have excellent communication and document...read more

Yes, I know integration.

• Integration is the process of combining different components or systems to work together seamlessly.

• It involves testing the interfaces between the components to ensure they communicate effectively.

• Examples of integration include integrating a payment gateway into an e-commerce website or integrating a CRM system with a marketing automation tool.

There are different types of integration such as vertical, horizontal, forward, backward, and bi-directional.

• Vertical integration involves the integration of different levels of the same supply chain.

• Horizontal integration involves the integration of different companies at the same level of the supply chain.

• Forward integration involves the integration of a company with its distributors or retailers.

• Backward integration...read more

Water content mechanism can be found through various methods and is important for various reasons.

• Water content can be measured through techniques such as gravimetric analysis, Karl Fischer titration, and moisture analyzers.

• Water content is important in industries such as food, pharmaceuticals, and cosmetics to ensure product quality and stability.

• Water content is also important in environmental studies to understand t...read more

Developing HPLC methods involves selecting appropriate columns and optimizing parameters.

• Choose a suitable column based on the analyte's properties and the separation goal.

• Optimize parameters such as mobile phase composition, flow rate, and temperature.

• Validate the method by assessing its selectivity, sensitivity, accuracy, and precision.

• Common column types include C18, C8, and phenyl.

• Other factors to consider include ...read more

Carbon loading in column refers to the amount of carbon used in the stationary phase of a chromatography column. Endcapping is a process to block the remaining silanol groups on the surface of the stationary phase.

• Carbon loading is typically expressed as a percentage of the total weight of the stationary phase.

• Higher carbon loading can improve the selectivity and retention of certain analytes.

• Endcapping is important to...read more

Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle.

• Data integrity ensures that data remains unchanged and reliable over time.

• It involves maintaining the accuracy and consistency of data during storage, processing, and transmission.

• Data integrity can be achieved through various measures such as checksums, encryption, and access controls.

• Examples of data integrity issues ...read more

CAPA stands for Corrective and Preventive Action.

• CAPA is a systematic approach to identify, investigate, and resolve quality issues.

• It involves analyzing the root cause of the problem and implementing corrective actions to prevent recurrence.

• CAPA is commonly used in industries such as manufacturing, pharmaceuticals, and healthcare.

• Examples of CAPA tools and techniques include 5 Whys, Fishbone Diagrams, and Pareto Analy

Calibration is required to ensure accuracy and consistency of measurements and equipment.

• Calibration helps to maintain the quality of products and services.

• It ensures that measurements are accurate and consistent, reducing errors and improving efficiency.

• Calibration is necessary for compliance with industry standards and regulations.

• Examples of equipment that require calibration include scales, thermometers, and medica...read more

I would clarify the reason behind the request and discuss any potential impact on the analysis.

• Ask for clarification on the reason for skipping the step

• Discuss any potential impact on the analysis

• Provide alternative solutions if possible

A 50 ppm solution contains 50 parts of solute per million parts of solution.

• ppm stands for parts per million.

• It is a measure of concentration.

• In a 50 ppm solution, there are 50 parts of solute per million parts of solution.

• For example, if we have a 1 million mL solution, there would be 50 mL of solute in it.