Akums Drugs & Pharmaceuticals Limited Quality Controller Interview Questions and Answers

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...read more

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

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...read more

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...read more

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 ...read more

I have over five years of experience in project management, leading teams to achieve operational excellence and drive business growth.

• Led a team of 10 in a project that increased efficiency by 20%, resulting in significant cost savings.

• Implemented a new software system that streamlined operations, reducing processing time by 30%.

• Managed cross-functional teams to deliver projects on time and within budget, enhancing cli...read more

MML line operation involves managing and overseeing the production process of a specific product line.

• Ensure smooth operation of the MML line by coordinating with production staff and addressing any issues that arise

• Monitor production output and quality to meet targets and standards

• Implement improvements to increase efficiency and reduce waste

• Train and develop team members to enhance their skills and performance

Humidity chambers maintain temperature and relative humidity through a combination of heating, cooling, and humidification systems.

• Humidity chambers use a combination of heating and cooling systems to control temperature.

• Humidification systems are used to control the relative humidity inside the chamber.

• Temperature and humidity sensors are used to monitor and adjust the conditions as needed.

• Examples of humidification s...read more

I would first check the equipment for any malfunctions, adjust settings if necessary, and calibrate the humidity sensor.

• Check the equipment for any malfunctions or leaks

• Adjust settings on the humidity chamber to reach the desired humidity level

• Calibrate the humidity sensor to ensure accurate readings

• Monitor the humidity levels regularly to maintain the desired range