Sanofi Quality System Specialist Interview Questions, Process, and Tips

It's was based on vigilance

Q1. How do u manage ur work and life
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Q1. What is difference between validation and qualification
Ans. 
Validation ensures that the system meets the user's needs, while qualification ensures that the system is installed and operates correctly.
• Validation confirms that the system meets the user's requirements and expectations.

• Qualification ensures that the system is installed correctly and operates within predefined specifications.

• Validation is more focused on user needs and expectations, while qualification is more focuse...read more
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Q2. What is GLP and data integrity
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GLP stands for Good Laboratory Practice, which ensures the reliability and integrity of data generated in a laboratory setting.
• GLP is a set of guidelines for conducting non-clinical safety studies on chemicals, pharmaceuticals, and other products.

• It includes requirements for the organization, personnel, facilities, equipment, and documentation of studies.

• Data integrity refers to the accuracy, completeness, and reliabil...read more
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Q1. What is HPLC and GC
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HPLC and GC are analytical techniques used in chemistry to separate and analyze compounds in a mixture.
• HPLC stands for High Performance Liquid Chromatography, which uses a liquid mobile phase to separate compounds based on their interactions with a stationary phase.

• GC stands for Gas Chromatography, which uses a gas mobile phase to separate compounds based on their volatility and interactions with a stationary phase.

• Bot...read more
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Q1. Normal questions about full profile with brief information
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Q1. Complete profiles review
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Q1. About your self location environment
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Q1. Type of Equipment Equipment cleaning contamination batch changing tipys of document data integrity ICH Q7 safety
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Q2. Type of equipment cleaning
Ans. 
Equipment cleaning involves thorough disinfection and sterilization to prevent contamination.
• Use appropriate cleaning agents and disinfectants recommended for the specific equipment

• Follow manufacturer's instructions for cleaning and maintenance

• Regularly inspect equipment for any signs of wear or damage

• Implement proper storage practices to prevent contamination

• Train staff on proper cleaning procedures and protocols
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Q3. Batch charging process
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Q4. Tipe of contamination
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Contamination can be classified into three main types: chemical, biological, and physical.
• Chemical contamination involves the presence of harmful chemicals in a substance or environment.

• Biological contamination refers to the presence of harmful microorganisms such as bacteria, viruses, or fungi.

• Physical contamination occurs when foreign objects like glass, metal, or plastic are present in a substance.
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Q1. What is the role of IPQA.
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IPQA stands for In-Process Quality Assurance. It involves monitoring and inspecting the quality of products during the manufacturing process.
• IPQA ensures that products meet quality standards at every stage of production

• It involves conducting inspections, tests, and audits to identify and address any quality issues

• IPQA helps in preventing defects and ensuring compliance with regulations and standards

• Examples include che...read more
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Q2. What is the ECR/BPR/BCR.
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ECR/BPR/BCR stands for Engineering Change Request/Business Process Reengineering/Business Case Reengineering.
• ECR (Engineering Change Request) is a formal proposal to make a change to a product's design or manufacturing process.

• BPR (Business Process Reengineering) is the analysis and redesign of workflows within and between enterprises to optimize end-to-end processes and eliminate non-value-added tasks.

• BCR (Business Ca...read more
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Q3. How to perform area clearance or equipment clearance.
Ans. 
Area or equipment clearance involves thorough cleaning and inspection to ensure safety and quality standards are met.
• Start by removing all items from the area or equipment being cleared.

• Clean the area or equipment using appropriate cleaning agents and tools.

• Inspect the area or equipment for any damage, wear and tear, or contamination.

• Document the clearance process and any findings for record-keeping purposes.

• Ensure pro...read more
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Q4. Review point of BPR/BCR/ECR
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BPR/BCR/ECR are review points in business process management.
• BPR stands for Business Process Reengineering, involves radical redesign of processes for improvement.

• BCR stands for Business Continuity Review, ensures processes are in place to maintain operations during disruptions.

• ECR stands for Engineering Change Review, evaluates proposed changes to products or processes for impact.

• Review points help ensure efficiency,
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Q1. Salary discussion and company policies
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Q1. What is gmp and ngmp
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GMP stands for Good Manufacturing Practice, which ensures products are consistently produced and controlled according to quality standards. NGMP is not a recognized term in this context.
• GMP is a set of guidelines for ensuring the quality and safety of products during manufacturing.

• GMP covers aspects such as personnel, premises, equipment, documentation, production, quality control, and more.

• Examples of industries that ...read more
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Q2. Solvent boiling point
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