Unichem Laboratories Senior Quality Assurance Officer Interview Questions and Answers

My daily activities as an In-Process Quality Assurance (IPQA) officer involve monitoring and ensuring quality standards are met during production.

• Conducting in-process inspections to verify product quality

• Reviewing production documentation for accuracy and compliance

• Identifying and addressing any quality issues or deviations

• Collaborating with production team to implement corrective actions

• Maintaining records of inspect

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

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

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

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

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

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

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

Reviews of PVR and PQRS can be conducted through a systematic process involving data analysis and evaluation.

• Collect and analyze data related to PVR and PQRS

• Evaluate the performance and quality based on established criteria

• Identify areas of improvement and develop action plans

• Implement changes and monitor the impact

• Continuously review and update the process to ensure ongoing quality assurance