Aurobindo Pharma Deputy Manager Interview Questions and Answers

CSV stands for Computer System Validation, which is a process used to ensure that a computerized system is fit for its intended use. Agile and V-Model are software development methodologies.

• CSV involves documenting and testing the system to ensure it meets regulatory requirements.

• Agile is a flexible and iterative approach to software development, focusing on delivering working software frequently.

• V-Model is a software ...read more

In my last organization, I successfully implemented a new performance management system that improved employee productivity and engagement.

• Implemented a new performance management system

• Improved employee productivity and engagement

• Conducted training sessions to educate employees on the new system

• Monitored and evaluated the effectiveness of the system through regular feedback and performance reviews

• Collaborated with HR ...read more

Process validation is the documented evidence that a process consistently produces a result meeting predetermined specifications.

• Process validation is a quality assurance technique used to confirm that a manufacturing process consistently produces a product that meets its intended specifications.

• It involves establishing documented evidence that the process is capable of consistently producing the desired output.

• Process...read more

Line clearance is a process of ensuring that a production line is free from any previous product, packaging material, or debris before starting a new production run.

• Identify the production line to be cleared

• Remove all previous products, packaging materials, and debris from the line

• Verify that the line is clean and free from any contaminants

• Document the line clearance process

• Authorize the line for the next production ru

Aseptic process simulation involves several steps to ensure the sterility of a process or environment.

• Prepare the aseptic environment by cleaning and disinfecting the area

• Assemble and sterilize all necessary equipment and materials

• Perform media fill or process simulation by introducing a sterile growth medium into the process

• Monitor and document the process, including environmental conditions and personnel behavior

• Incu...read more

Change management involves planning, implementing, and monitoring changes to ensure successful outcomes.

• Identify the need for change

• Develop a plan for change

• Communicate the change to stakeholders

• Implement the change

• Monitor and evaluate the change

• Example: Implementing a new software system in a company

• - Identify the need for a new system

• - Develop a plan for implementation

• - Communicate the change to employees and stakeho...read more

Deviation management procedure involves identifying, documenting, investigating, and resolving any deviations from established processes or procedures.

• Deviation is identified and documented

• Investigation is conducted to determine the root cause

• Corrective and preventive actions are taken

• Follow-up is done to ensure effectiveness

• Examples include non-conformance reports, change control procedures, and corrective action plan

Complaint and event investigation procedures involve thorough analysis and documentation of incidents.

• Gather all relevant information and evidence

• Interview witnesses and involved parties

• Analyze the root cause of the incident

• Document findings and recommendations for corrective action

• Follow up to ensure corrective action is taken

• Example: Investigating a customer complaint about a faulty product

• Example: Investigating an e

CAPA effectiveness check is performed through a systematic process of evaluating the implemented corrective actions.

• The effectiveness of the corrective actions is evaluated by comparing the actual results with the expected results.

• The effectiveness check is performed to ensure that the root cause of the problem has been eliminated.

• The effectiveness check is also performed to ensure that the problem does not recur.

• The e...read more

The training management system is handled through a combination of online modules, in-person training sessions, and ongoing coaching and feedback.

• We use a learning management system to deliver online training modules.

• In-person training sessions are conducted by experienced trainers.

• We provide ongoing coaching and feedback to ensure continuous improvement.

• We regularly evaluate the effectiveness of our training programs

Precautions for handling solvents in the area

• Ensure proper ventilation in the area to prevent the buildup of fumes

• Use appropriate personal protective equipment (PPE) such as gloves, goggles, and masks

• Store solvents in designated containers and away from heat sources

• Follow proper labeling and handling instructions provided by the manufacturer

• Implement proper spill control measures and have spill kits readily available

• Tr...read more

Recently, I performed troubleshooting on a malfunctioning production machine.

• Identified the root cause of the issue

• Analyzed the machine's performance logs

• Collaborated with the maintenance team to resolve the problem

• Implemented preventive measures to avoid future breakdowns

Change control is a process of managing changes to a system or process to ensure they are implemented in a controlled and systematic manner.

• Change control involves documenting and tracking changes

• Changes should be reviewed and approved before implementation

• Examples include software updates, process changes, and equipment modifications

SOP preparation involves creating a document that outlines the standard procedures for a particular task or process.

• SOPs should be clear and concise

• They should include step-by-step instructions

• They should be regularly reviewed and updated

• They should be easily accessible to all relevant personnel

• Examples of SOPs include those for safety procedures, quality control, and customer service