Syngene International Interview Questions, Process, and Tips

Q1. What is sink condition.
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Q2. BCS Classification
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Q3. Outline the OOT and OOS investigation
Ans. 
OOT and OOS investigations are conducted to determine the root cause of results that are out of specification or out of trend.
• Identify the OOT or OOS result

• Isolate the sample for further testing

• Investigate potential causes such as equipment malfunction or human error

• Document findings and corrective actions taken

• Review and approve investigation report
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Q4. What is the CMC and limits
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Q5. Types of surfactants and limits
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Surfactants are classified into four main types: anionic, cationic, nonionic, and amphoteric, each with specific limits and applications.
• Anionic surfactants have a negatively charged head group and include sulfates, sulfonates, and carboxylates.

• Cationic surfactants have a positively charged head group and are often used as fabric softeners or antimicrobial agents.

• Nonionic surfactants have no charge and are commonly use...read more
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Q6. Brief about RS method development
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RS method development involves creating and optimizing analytical methods for the analysis of raw materials and finished products.
• RS method development includes selecting appropriate analytical techniques based on the properties of the sample.

• It also involves optimizing parameters such as sample preparation, chromatographic conditions, and detection methods.

• Examples of RS method development include developing HPLC meth...read more
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Q1. Saturation solubility as per WHO
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Q2. Contents of SOP
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SOP (Standard Operating Procedure) outlines the steps and guidelines for performing a specific task or process.
• SOPs detail step-by-step instructions

• Include safety precautions and quality control measures

• Should be clear, concise, and easy to follow

• May include diagrams, flowcharts, or checklists

• Regularly reviewed and updated to reflect current best practices
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Q3. Difference between validation and verification
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Validation ensures the right product is being built, while verification ensures the product is being built right.
• Validation confirms that the product meets the customer's requirements and needs.

• Verification ensures that the product is being built according to the specifications and design.

• Validation is about checking if we are building the right product, while verification is about checking if we are building the produ...read more
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Q4. Brief about Dissolution development
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Q5. 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 changes to data

• Maintaining consistency of data across systems

• Implementing data validation processes

• Regularly auditing data to ensure integrity
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Q6. What is cGMP and why it is important
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Q7. Significant changes
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Significant changes refer to major modifications or transformations in a particular aspect or area.
• Significant changes can include shifts in strategy, technology, personnel, or processes.

• Examples of significant changes may include implementing a new software system, restructuring a department, or launching a new product line.

• These changes often require careful planning, communication, and execution to ensure successful
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Q1. Why your changing the organization.
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Q2. Where you want be in 5 years
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Q3. What we can expect from you
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Q4. What your expecting from us
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Q5. Brief about deviation management
Ans. 
Deviation management involves identifying, documenting, investigating, and resolving any deviations from standard procedures or specifications.
• Deviation management is a process used to address any deviations from established procedures or specifications.

• It involves documenting the deviation, investigating the root cause, and implementing corrective actions to prevent recurrence.

• Examples of deviations include equipment ...read more
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Q6. How you handle incidents
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I handle incidents by remaining calm, assessing the situation, taking appropriate action, and following up to prevent future occurrences.
• Remain calm and composed during the incident

• Assess the situation to determine the severity and necessary actions

• Take appropriate steps to address the incident effectively

• Follow up to analyze the root cause and implement preventive measures

• Communicate effectively with team members and
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Q7. What is your role in investigations
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Q1. Validation life cycle approach
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Q2. Change management system
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Q1. ERP Systems Implementation and handling
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Q2. Sequence of validation deliverables
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Versant and Data integrity verification

Q1. Past experience discussions and salary requirements
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Q2. Expectations and work culture
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Q3. HR policy and reporting
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Q1. What is the reason for your job change?
Ans. 
Seeking new challenges and growth opportunities in a larger organization.
• Desire for career advancement

• Opportunity to work in a larger organization

• Seeking new challenges
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Q1. Why does methionine not form a disulfide bond?
Ans. 
Methionine does not form a disulfide bond due to the presence of a sulfur atom in its side chain.
• Methionine contains a sulfur atom in its side chain, which prevents it from forming a disulfide bond with another sulfur-containing amino acid.

• Disulfide bonds are formed between cysteine residues, which have sulfur atoms in their side chains that can form covalent bonds.

• Methionine is often the first amino acid in a protein ...read more
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Q2. What is the molecular weight of Endotoxin? How do we get rid of from protein contamination?
Ans. 
Endotoxin has a molecular weight of approximately 10-20 kDa. Protein contamination can be removed through methods such as affinity chromatography, ion exchange chromatography, and size exclusion chromatography.
• Endotoxin has a molecular weight of approximately 10-20 kDa

• Methods to remove protein contamination include affinity chromatography

• Other methods include ion exchange chromatography and size exclusion chromatograph
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Q1. Tell me Your self
Ans. 
I am a dedicated Maintenance Engineer with a strong background in mechanical and electrical systems.
• Experienced in troubleshooting and repairing equipment

• Skilled in preventive maintenance tasks

• Familiar with PLC programming and automation systems

• Certified in safety protocols and regulations
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Q2. Sallary
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Q1. Pandas Manipulation
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Q1. What is your exact roles and responsibility
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Q2. How to manage difficult situation
Ans. 
Managing difficult situations involves staying calm, listening actively, finding solutions, and maintaining professionalism.
• Stay calm and composed to assess the situation objectively

• Listen actively to understand the root cause of the difficulty

• Find solutions by brainstorming with team members or seeking advice from mentors

• Maintain professionalism and communicate effectively with all parties involved
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