Macleods Pharmaceuticals Senior QC Officer Interview Questions, Process, and Tips

Q1. How many ICH guidelines?, and it's topics
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Q2. Dissolution criteria for extended release drug
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Q3. ALCOA++ related questions
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Q4. Type of Audit trail?
Ans. 
Audit trails are logs that track changes made to data, providing a record of who made the changes, when, and why.
• Audit trails are essential for maintaining data integrity and compliance with regulations.

• They help in identifying errors, fraud, or unauthorized access to data.

• Examples of audit trails include logs of user actions in a software system, changes made to a document, or modifications to a database.

• Audit trails ...read more
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Q5. What is the formula for calculating CU value or for AV
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The formula for calculating CU value or AV is based on the number of defects found during quality control inspections.
• CU value (Criticality Unit) is calculated by assigning a weight to each type of defect based on its impact on the product or process.

• AV (Acceptance Value) is calculated by summing up the CU values of all defects found during inspections.

• Formula: AV = Σ(CU value of all defects)

• Example: If a product has 3...read more
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Q6. What are the check points for dissolution test?
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Check points for dissolution test include equipment calibration, sample preparation, media selection, temperature control, and data analysis.
• Calibrate equipment regularly to ensure accurate results

• Properly prepare samples to ensure consistency

• Select appropriate media for dissolution based on drug solubility

• Maintain proper temperature control throughout the test

• Analyze data accurately to determine dissolution rate
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Q7. What is UCL and LCL? And how they calculated?
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UCL and LCL stand for Upper Control Limit and Lower Control Limit, respectively. They are statistical measures used in quality control to determine if a process is stable and in control.
• UCL is the highest value that a process can reach before it is considered out of control.

• LCL is the lowest value that a process can reach before it is considered out of control.

• UCL and LCL are typically calculated using statistical meth...read more
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Q8. If any extraneous peak observe in GC analysis, then how can you handle that?
Ans. 
Extraneous peaks in GC analysis can be handled by identifying the source of contamination, adjusting parameters, and re-analyzing the sample.
• Identify the source of contamination by checking sample preparation, column condition, or instrument cleanliness.

• Adjust parameters such as temperature, flow rate, or injection volume to minimize extraneous peaks.

• Re-analyze the sample after making necessary adjustments to ensure ac...read more
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Q9. Which are the stability zones, and thier conditions?
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Q10. How to handle NQI and QI or decesion power to take incident or not?
Ans. 
Handling NQI and QI incidents requires thorough evaluation and decision-making based on established protocols.
• Thoroughly investigate the incident to determine if it falls under NQI (Non-Quality Incident) or QI (Quality Incident).

• Refer to established guidelines, protocols, and quality standards to assess the severity and impact of the incident.

• Consider the potential risks to patient safety, regulatory compliance, and ov...read more
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Q1. Why are you left your current organisation?
Ans. 
Seeking new challenges and opportunities for growth.
• Desire for new challenges and opportunities for professional growth

• Looking for a more supportive work environment

• Seeking better work-life balance

• Company restructuring or downsizing

• Relocation to a different city or country
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Q2. How much rise you want?
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I am open to discussing a rise based on my qualifications, experience, and the responsibilities of the role.
• I am looking for a competitive salary that reflects my skills and experience.

• I am open to negotiation based on the responsibilities and expectations of the role.

• I would like to discuss the potential for performance-based bonuses or incentives.

• I am interested in opportunities for career growth and development with
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Q1. Explain data integrity in pharma industry
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Q2. Explain oos and incident
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OOS stands for Out of Specification and refers to test results that fall outside the acceptable range. Incidents are unexpected events that may impact product quality.
• OOS results indicate a deviation from the specified requirements or standards.

• Incidents are unexpected events that may impact product quality or safety.

• OOS results may require investigation to determine the root cause and corrective actions.

• Examples of in...read more
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Q1. What is data integrity
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Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle.
• Ensuring data is accurate and reliable

• Preventing unauthorized access or modifications

• Maintaining consistency and completeness of data

• Implementing security measures to protect data integrity
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Q2. Family background why you shifting job
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I am shifting jobs to pursue better career growth opportunities and to utilize my skills and experience in a new environment.
• Seeking better career growth opportunities

• Utilizing skills and experience in a new environment

• Exploring new challenges and responsibilities
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Q1. Family background
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Q2. Qualification and previous experience
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It is extremely tough and hard

Q1. What is sop stands for
Ans. 
SOP stands for Standard Operating Procedure.
• SOP is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations.

• It ensures consistency and quality in the performance of tasks.

• Examples include SOPs for laboratory testing procedures, manufacturing processes, and safety protocols.
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Q2. What is GMP stands for
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GMP stands for Good Manufacturing Practice.
• GMP is a set of guidelines that ensure products are consistently produced and controlled according to quality standards.

• It is important in industries such as pharmaceuticals, food, and cosmetics.

• Examples of GMP requirements include proper documentation, sanitation, and quality control measures.
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Q1. Departments related
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Q2. What is the FMCG Industry
Ans. 
FMCG stands for Fast Moving Consumer Goods. It refers to products that are sold quickly and at a relatively low cost.
• FMCG industry includes products like food and beverages, personal care items, household cleaning products, and tobacco.

• These products have a short shelf life and are consumed on a daily or regular basis.

• FMCG companies focus on mass production, distribution, and marketing to reach a wide consumer base.

• Exa...read more
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Q3. Why do you work in a FMCG plants
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I work in FMCG plants because I am passionate about ensuring the quality of consumer products.
• I have a strong interest in quality control and ensuring that products meet high standards

• I enjoy working in a fast-paced environment and FMCG plants provide that

• I find it rewarding to contribute to the production of safe and reliable consumer goods

• I appreciate the opportunity to work with a diverse range of products and proce...read more
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Range problem so i cant give to this aptitude test

Q1. All about Qc HPLC Gas C
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Q1. Based on resume what we mention in resume
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Q2. Experience and pakage matters
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Q1. About related microbiology , Environmental monitoring in specific areas and levels, water sampling.
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