Meril Regulatory Affairs Officer Interview Questions and Answers

Q1. Steps of manufacturing process of solids with in-process controls
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Q1. B. Pharm basics like granulation etc.
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Q1. What did you achieved in last organization?
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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
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Q2. What is sterilization process?
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Q3. What is process Validation?
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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
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Q4. What are steps of line clearance?
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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
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Q5. What are steps of aseptic process simulation?
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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
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Q1. How change management is being done? Explain with example.
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Q2. Explain with example, deviation management procedure.
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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
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Q3. Explain with example, complaint investigation as well as event investigation procedure.
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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
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Q4. How CAPA effectiveness check is being performed?
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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
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Q5. How the training management system is being handled?
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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
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Q1. What is your hobbie?
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Q2. You are comfortable to shift work ?
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Q1. Regards experience and area of exposure
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Q1. Regards experience and CTC
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Q1. Regarding Operation and shift handling
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Q1. MML line operation
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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
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Q1. Job role, past work experience and current role understanding
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Q1. Interaction with the department head on subject knowledge
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Psychometric test to judge behaviour and leadership skills

Q1. Job role, work profile, cv excerpts, and current role understanding
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Q1. Work role, profile understanding, CV assesment, and skill set
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Psychometric test to check leadership abilities