Hikal Regulatory Affairs Officer Interview Questions and Answers

Q1. Flow of change control
Ans. 
Flow of change control refers to the process of managing changes to a project or system.
• Change requests are submitted and reviewed by a change control board

• The board evaluates the impact of the change and decides whether to approve or reject it

• If approved, the change is implemented and tested

• Documentation is updated to reflect the change

• The change control process ensures that changes are made in a controlled and system...read more
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Q2. How to handle inprocess check failure mrtal dectector
Ans. 
Inprocess check failure of metal detector can be handled by following proper procedures and protocols.
• Immediately stop the production line and isolate the affected product.

• Investigate the cause of the failure and take corrective actions.

• Notify the quality control department and involve them in the investigation.

• Conduct a thorough inspection of the metal detector and ensure it is functioning properly before resuming pro...read more
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Q3. Factor affecting weight variation during compression.
Ans. 
Factors affecting weight variation during compression include formulation, equipment, and process parameters.
• Formulation: particle size, shape, and density, excipient type and concentration

• Equipment: type of tablet press, tooling, and compression force

• Process parameters: compression speed, dwell time, and pre-compression force

• Example: changing the excipient concentration can affect the weight variation of tablets

• Exampl...read more
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Q4. What is 21 CFR part 11
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Q5. Why you looking for change
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Q1. What is OEE of equipment
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Q2. How to improve productivity in manufacturing
Ans. 
Improving productivity in manufacturing involves optimizing processes, reducing waste, and investing in technology.
• Analyze current processes and identify areas for improvement

• Implement lean manufacturing principles to reduce waste and increase efficiency

• Invest in automation and technology to streamline production

• Provide training and development opportunities for employees to improve skills and knowledge

• Establish clear ...read more
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Q3. How to handle the man power, they're in unions
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Q4. What is Operational excellence
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Operational excellence is the continuous improvement of processes and systems to achieve maximum efficiency and effectiveness.
• It involves identifying and eliminating waste and inefficiencies in processes

• It focuses on improving quality, reducing costs, and increasing productivity

• It requires a culture of continuous improvement and employee engagement

• Examples include Lean Six Sigma, Total Quality Management, and Kaizen

• Ope...read more
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Q1. With Manager to be
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Q1. Technical Questions About the Job Role
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Project given to test capability

Psychometric Evaluation

Q1. HR round with HR Head
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Logical and reasonable questions necessitate thorough study.

Q1. What questions can I expect to be asked based on my CV?
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Q2. Same as above mentioned statement.
Ans. 
The question seeks to understand your approach to a specific situation or challenge in management.
• Identify the key challenges faced in the situation.

• Outline your strategic approach to address these challenges.

• Provide examples of similar situations you've handled successfully.

• Discuss the importance of teamwork and communication in your approach.
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Q3. Same As above statement.
Ans. 
The question seeks to understand your approach to problem-solving and decision-making in a managerial role.
• Identify the problem clearly before proposing solutions.

• Gather relevant data and insights from team members.

• Consider multiple perspectives and potential impacts of decisions.

• Example: In a previous role, I improved team efficiency by implementing a new project management tool after analyzing workflow bottlenecks.

• Co...read more
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To understand if you're a possible fit by checking your experience/proficiencies with what's required for the role

Q1. Technical Questions Round - Industry, Tools, Skills etc.
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Assignment based on role and function similar and related to daily scope of work

Psychometric Evaluation

Q1. With Manager to discuss Salary and Specifics
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Q1. Technical purely
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Q2. Background exprience
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Q1. What is the rule or guideline to keep fire extinguishers?
Ans. 
Fire extinguishers should be kept in easily accessible locations throughout a building.
• Fire extinguishers should be placed on every floor of a building.

• They should be easily visible and accessible, preferably mounted on walls or placed on stands.

• Fire extinguishers should be located near potential fire hazards, such as kitchens or electrical equipment.

• They should be placed in well-lit areas and not obstructed by furnitu...read more
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