Unichem Laboratories Senior Quality Assurance Officer Interview Questions and Answers

Q1. What is the role of Medicine in future.
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Q2. Where to see this industry in Pharma role to Future Aspects?
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Discuss about people healthy life

Q1. Job responsibilities
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Q2. Quality assurance questions
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Q1. Tell me about change Control? And give me One Example?
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Change control is a process used to manage and document changes to a system or process.
• Change control ensures that changes are properly reviewed, approved, and implemented.

• It helps to minimize risks and ensure that changes do not negatively impact the quality or functionality of the system.

• Change control typically involves documenting the change request, assessing its impact, obtaining necessary approvals, implementing...read more
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Q2. What are the ypes of Process validation?
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Process validation is the process of establishing documented evidence that a process consistently produces a product meeting predetermined specifications.
• There are three types of process validation: prospective validation, concurrent validation, and retrospective validation.

• Prospective validation is conducted before the process is put into routine use.

• Concurrent validation is performed during routine production.

• Retrosp...read more
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Q3. How you are doing Audit trail?
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Audit trail is maintained by documenting and tracking all activities and changes made to a system or process.
• Audit trail is created by recording all actions, events, and transactions that occur within a system.

• It helps in ensuring accountability, traceability, and compliance with regulations.

• Audit trail can be established through the use of logs, timestamps, and version control.

• It is important to capture relevant infor...read more
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Q4. Asking about APQR
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Q5. Are you interested in Microbiology analytical review?
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Yes, I am interested in Microbiology analytical review.
• I have a strong background in microbiology and enjoy analyzing data in this field.

• I have experience conducting microbiological tests and interpreting the results.

• I am familiar with various microbiological techniques and methodologies.

• I am interested in staying updated with the latest advancements in microbiology research.

• I believe that my knowledge and skills in mi...read more
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Q1. Purified water specification?
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Purified water specification refers to the set of requirements and standards that purified water must meet.
• Purified water should have a low level of impurities, such as minerals, chemicals, and microorganisms.

• It should meet the specifications outlined by regulatory bodies, such as the United States Pharmacopeia (USP) or European Pharmacopoeia (EP).

• The pH level of purified water should be within a specific range, typica...read more
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Q2. Purified water specification of Microbal
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The purified water specification for microbial quality assurance.
• Microbial specification for purified water is crucial to ensure its safety and suitability for use.

• The specification typically includes limits for various microorganisms, such as bacteria, fungi, and endotoxins.

• Commonly used tests for microbial quality assessment include total viable count, microbial identification, and endotoxin testing.

• The specification...read more
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Q3. USP chapters of Microbial tesing of API and water
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Q4. Growth Pramotion tests
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Q5. Horizontal Autoclave validation
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Q6. Types of validation
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Validation is the process of evaluating a system or component during or at the end of the development process to determine whether it satisfies specified requirements.
• Functional Validation: Ensuring that the system meets the functional requirements.

• Performance Validation: Verifying that the system performs as expected under different load conditions.

• Security Validation: Checking the system for vulnerabilities and ensur...read more
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Q1. Tell me about your self
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Q2. Are you willing to shift Vizag
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Q3. Salary discussion
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Q1. Your salary expectation
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Q1. Questions about your profile mentioned in your resume
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Q1. Different between QA and QC
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QA focuses on preventing defects in the process, while QC focuses on identifying defects in the product.
• QA is process oriented, focusing on preventing defects by establishing processes and standards.

• QC is product oriented, focusing on identifying defects through testing and inspection.

• QA involves activities like process audits, training, and documentation.

• QC involves activities like product testing, inspections, and sa...read more
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Q2. Types of defect
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Types of defects include functional, performance, cosmetic, and compatibility issues.
• Functional defects affect the core functionality of the product or system.

• Performance defects impact the speed, response time, or resource usage.

• Cosmetic defects are related to the appearance or aesthetics of the product.

• Compatibility defects arise when the product does not work well with other systems or devices.
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Standard of coding and defect of coding

Q1. Discuss about your project?
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Q1. Discuss about subject related like disease and drugs
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Q2. Discuss about Quality management system and Data integrity
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Q1. What's is meanM30
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Q2. Soil classification
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