Lonza Quality Executive Interview Questions and Answers

Q1. Related to Lab work and LIMS
Ans. Explained all details about lab work and how it co-relate with LIMS
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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. Related to Good clinical practic
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Q2. BA BE guidelines for conducting studies
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Q1. AAS principle and it’s application
Ans. 
AAS principle refers to the three key elements of authentication, authorization, and accounting in information security.
• Authentication: verifying the identity of a user or system

• Authorization: granting access to specific resources based on the user's identity and permissions

• Accounting: tracking and logging user activity for auditing and compliance purposes

• Example: A user logging into a system with a username and passwo...read more
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Q1. Tell me about Forced degradation study
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Forced degradation study is a process used to determine the stability of a drug substance or product under various stress conditions.
• Forced degradation studies involve subjecting the drug to conditions such as heat, light, humidity, and acid/base hydrolysis to simulate potential degradation pathways.

• The purpose of these studies is to identify degradation products, determine degradation pathways, and establish the stabi...read more
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Q2. Explain about Validation parameters
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Validation parameters are criteria used to ensure data input meets specified requirements.
• Validation parameters can include data type, length, format, range, and presence.

• For example, a validation parameter for a phone number field may require 10 digits and no special characters.

• Validation parameters help prevent errors and ensure data integrity.

• They are commonly used in form fields and database entries.
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Q3. Explain the problems faced in validations
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Validations in executive roles can face challenges due to lack of data accuracy, timeliness, and stakeholder alignment.
• Data accuracy issues can lead to incorrect decisions being made.

• Timeliness of data can impact the speed at which decisions can be made.

• Lack of stakeholder alignment can result in conflicting priorities and goals.

• Inconsistent validation processes across departments can lead to discrepancies in data inte
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Q4. Explain about validation plan
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A validation plan outlines the process for ensuring that a product or system meets specified requirements and standards.
• Defines the objectives and scope of validation activities

• Identifies the resources, responsibilities, and timelines for validation

• Specifies the methods and procedures for testing and evaluating the product or system

• Includes criteria for acceptance and rejection of validation results
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Q5. Calibration of HPLC
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Calibration of HPLC is a process of adjusting the settings of the High Performance Liquid Chromatography system to ensure accurate and reliable results.
• Calibration involves checking and adjusting the flow rate, detector sensitivity, and column efficiency.

• Regular calibration helps maintain the accuracy and precision of the HPLC system.

• Calibration standards are used to verify the performance of the system.

• Documentation o...read more
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Q1. Related to IPQA activities and Manufacturing process and QMS
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