Strides Pharma QA Chemist Interview: Rounds, Questions and Preparation

What the job involves

A QA Chemist in the pharmaceutical sector ensures that raw materials, in-process samples, and finished drug products meet established quality standards before release. Day to day, they perform wet-lab analysis, operate instruments like HPLC and UV-Vis, document results in compliance with GMP and GDP, and investigate out-of-specification results. At a company like Strides Pharma, this role supports regulatory audits and maintains data integrity across the product lifecycle.

Role and Technical Knowledge

1. 1

   What is the difference between quality control and quality assurance in a pharmaceutical company?

   Explain that QC focuses on testing and release of materials, while QA ensures the entire quality system and processes comply with regulations. Give an example like QC testing a batch versus QA auditing documentation.

2. 2

   Which pharmacopoeial standards are commonly used in India for drug testing, and how do they differ?

   Mention Indian Pharmacopoeia (IP), United States Pharmacopeia (USP), and British Pharmacopoeia (BP). Highlight that they may have different acceptance criteria or methods for the same product, and you must follow the one registered for that market.

3. 3

   Explain the principle of HPLC and its importance in a QA lab.

   Describe separation based on partitioning between mobile and stationary phases, and detection by UV or other detectors. Emphasise its use for assay, related substances, and dissolution testing with high precision.

4. 4

   What is the meaning of ALCOA+ in data integrity?

   List Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available. Explain how each applies to lab records and electronic data.

Practical Scenarios and Troubleshooting

1. 5

   You are performing an assay by HPLC and the system suitability fails. What steps do you take?

   Outline checking mobile phase preparation, column condition, detector settings, and sample preparation. Mention documenting the failure, investigating root cause, and repeating only after correcting the issue as per SOP.

2. 6

   During a dissolution test, one tablet gives a result outside the specification. How do you proceed?

   Describe immediately informing the supervisor, not discarding the sample, and initiating an OOS investigation. Cover checking for analyst error, instrument calibration, and then following the approved OOS procedure.

3. 7

   How would you handle a situation where you realise you made a mistake in a lab notebook entry?

   State that you should not overwrite or erase. Instead, strike through with a single line, write the correction, initial and date it, and provide a reason if required. This maintains data integrity.

4. 8

   What do you do if a reagent bottle is unlabelled or expired?

   Explain that you must not use it, quarantine it immediately, and inform the lab supervisor. Follow the SOP for disposal or relabelling, and ensure no testing is affected.

Behavioural and Situational Questions

1. 9

   Tell me about a time you had to follow a detailed procedure under time pressure.

   Use the STAR method. Focus on a lab or academic project where you prioritised accuracy over speed and still met the deadline without compromising quality.

2. 10

   How do you handle repetitive tasks while maintaining attention to detail?

   Give an example of a routine activity you did, such as sample preparation or documentation, and explain how you used checklists or peer review to stay accurate.

3. 11

   Describe a situation where you disagreed with a teammate about a test result. How did you resolve it?

   Show that you relied on data and SOPs rather than personal opinion. Mention discussing with the supervisor and repeating the test to confirm the correct result.

4. 12

   Why do you want to work in quality control rather than research and development?

   Highlight your interest in compliance, patient safety, and the satisfaction of ensuring every batch is safe. Mention that QC offers structured work with clear regulations.

HR and Company Fit

1. 13

   Are you comfortable working in shifts, including night shifts, in a manufacturing plant?

   Answer honestly and positively. If you are flexible, state that you understand pharma production runs 24/7 and you are willing to adapt.

2. 14

   What do you know about Strides Pharma and its product portfolio?

   Mention that it is a global pharma company with a focus on niche generics, injectables, and regulated markets. Show that you researched its quality commitments and recent developments.

3. 15

   Where do you see yourself in three years in this role?

   Express a desire to deepen technical expertise, take on more responsibility like method validation or audit support, and grow within the quality function.

4. 16

   How would you handle a senior colleague asking you to skip a documentation step to save time?

   State politely but firmly that you cannot bypass GMP or data integrity requirements. Suggest finding a compliant way to meet the timeline and escalating if needed.