Solara Active Pharma Sciences Senior Manager Interview Questions and Answers

Q1. What was your work profile and did you have exposure to multiple locations
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Q2. What is your exposure to quality systems and CSV
Ans. 
I have extensive exposure to quality systems and CSV.
• I have implemented and maintained quality systems such as ISO 9001 and GMP.

• I have experience in Computer System Validation (CSV) for regulated industries.

• I have conducted CSV audits and ensured compliance with regulatory requirements.

• I have trained teams on quality systems and CSV best practices.

• I have worked with cross-functional teams to ensure quality and complian
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Q1. Which was the toughest task handled by you
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Q2. What you feel is unique achievement
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Q1. What is your current job profile?
Ans. My current job profile is handling Quality management systems of R&D.
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Q2. How Many Projects are handled by you?
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Q3. What was your achievement in previous company?
Ans. I have answered Chemistry manufacturing control queries and quality issues as subject matter expert from the R&D.I have done gap analysis of queries from various EU Regulatory Agencies. Gap submitted CMC Data by MAH and expectation of agency as per EMA Guideline. We have bridged that gap between our upcoming projects. I was part of the team filing 505(b2) project and Product got approval from the US Agency.
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Q4. Any improvement done by you in the company?
Ans. Stability study at R&D was improved by implementing SOP and deviations were closed by implementing CAPA. Every anomaly in stability study reports was documented through incident report form and corrected in future projects. Cross functional team were educated about gaps in the system and training was imparted by giving practical examples.
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Q5. What is your strength?
Ans. I have strong background of RA that help me understand expectation of the agencies. Quality can be in built in the Product at the time of development. Robust product will meet challenges of the scale up at Manufacturing site.
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Q1. What is your current CTC?
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Q2. What is your expectation of CTC?
Ans. 
My expectation of CTC is based on my experience, skills, and the responsibilities of the Senior Manager role.
• Consider the market value for Senior Manager positions in the industry

• Take into account the company's financial health and compensation structure

• Factor in the level of responsibility and scope of the role

• Consider the benefits and perks offered by the company

• Be open to negotiation based on the overall package off
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Q3. What is your notice period?
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Q1. Problem solving skills,
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Q2. Leadership qualities, techical skills, subject knowledge
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Q1. SOLID Principles
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Q2. Basic OOPS concepts
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Q3. Programming patterns
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Q4. Factory Design Pattern
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Q5. Basic Angular Questions
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Aptitude interpersonal english grammar

Q1. Work Experience
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Q2. Skills having technical ability
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Q1. Why Do you want to change
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Q2. Notice period time relocation
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Q1. How can calculate HVAC efficiency
Ans. 
HVAC efficiency can be calculated by dividing the useful output by the total input.
• Calculate the useful output of the HVAC system, such as the amount of heating or cooling provided to the space.

• Determine the total input of the HVAC system, including the energy consumed by the system.

• Divide the useful output by the total input to get the efficiency percentage.

• Efficiency (%) = (Useful Output / Total Input) * 100

• For examp...read more
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Q2. What is filter integrity test and how to do.
Ans. 
Filter integrity test is a method to ensure the filter is functioning properly by testing its ability to retain particles of a certain size.
• Filter integrity test is performed to verify the effectiveness of a filter in retaining particles of a specific size.

• Common methods include bubble point test, diffusion test, pressure hold test, and water intrusion test.

• The test results are compared against established acceptance c...read more
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Q3. Area classification as per USFDA guidelines and ISO guidelines
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Q4. How can perform PAO test. And concentration ratio
Ans. 
Performing PAO test involves measuring the concentration ratio of a substance in a solution.
• Prepare a known concentration of the substance to be tested

• Measure the absorbance of the solution at a specific wavelength using a spectrophotometer

• Plot a standard curve using known concentrations of the substance

• Calculate the concentration of the unknown sample using the standard curve

• Concentration ratio can be calculated by di...read more
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Q5. Class ISO 7 partical count
Ans. 
ISO 7 particle count refers to the cleanliness level of air in a controlled environment.
• ISO 7 classifies air cleanliness based on the number of particles per cubic meter.

• Lower particle counts indicate cleaner air and higher particle counts indicate more contamination.

• ISO 7 is commonly used in cleanrooms and controlled environments to maintain quality standards.

• Example: ISO 7 particle count may be 10,000 particles per c
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Q6. What is DX coil
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DX coil is a type of coil used in air conditioning systems to transfer heat between the indoor and outdoor units.
• DX coil stands for Direct Expansion coil

• It is a key component in air conditioning systems

• DX coils are used to transfer heat between the refrigerant and the air being circulated in the system

• They are commonly found in split air conditioning systems
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Q1. You experienced related questions.what your preasent job role questions.
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Q2. Dispatch activity, vendor qualification, process validation,PQR preparation like.
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Q3. Which guideline recently revised By ICH
Ans. ICHQ9QUALITY RISK MANAGEMENT Q9(R1) Final version Adopted on 18 January 2023
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Q4. Cleaning validation reference guideline
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Q5. PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME(PIC/S).
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Q6. Recent ICH Q13&14
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The assignment was mostly based on the incentive compensation design

Q1. The question was more focused on the second level responsibilities to handle a team
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