FDC Limited QA Chemist Interview: Rounds, Questions and Preparation

What the job involves

A QA Chemist in a pharma company like FDC Limited tests raw materials, in-process samples, and finished drug products to confirm they meet pharmacopoeial and company specifications. They perform wet chemistry and instrumental analysis, document results in compliance with GMP and data integrity rules, and support investigations when out-of-specification results occur. The role is lab-based and highly regulated, so accuracy, documentation, and adherence to SOPs matter as much as hands-on technique.

Role and technical knowledge

1. 1

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

   Explain that QC tests and releases materials and products, while QA builds the systems, audits, and documentation that prevent errors. Show that you understand both work together for product safety.

2. 2

   Which pharmacopoeias are commonly used in Indian pharma QC, and why does it matter which one you follow?

   Mention Indian Pharmacopoeia, British Pharmacopoeia, and United States Pharmacopeia. State that the applicable pharmacopoeia depends on the product's market and that methods and limits can differ, so you must follow the registered specification.

3. 3

   Explain how you would perform an assay of a drug substance by titration.

   Outline weighing accurately, preparing the titrant, standardising it, adding indicator if required, titrating to the endpoint, and calculating percentage purity using the molarity and equivalence factor. Mention recording raw data in the notebook immediately.

4. 4

   What is the principle of HPLC and what are the main components of an HPLC system?

   Describe separation based on partitioning between mobile and stationary phases. List pump, injector, column, detector, and data system. Add that in QC you run system suitability before sample analysis.

Practical scenarios and problem solving

1. 5

   You get an out-of-specification result for a finished product assay. What do you do next?

   Say you immediately stop, inform your supervisor, and follow the OOS SOP. Do not discard the sample or repeat the test on your own. Describe a phase I lab investigation for assignable cause before any retesting is approved.

2. 6

   During a dissolution test, the results are variable across vessels. How would you approach this?

   Check for obvious causes such as vessel alignment, paddle height, media temperature, and degassing. Verify the instrument calibration and the method parameters. Then escalate through the deviation system if the variability persists.

3. 7

   How do you handle a situation where you realise you made an error in a laboratory notebook entry?

   Explain that you strike through with a single line, write the correction, initial and date it, and give the reason if required. Never overwrite, erase, or use correction fluid. This shows you understand data integrity.

4. 8

   What would you check before releasing a raw material for production use?

   Cover approved vendor status, correct sampling as per SOP, completion of all specified tests, compliance with specification, and review by a second person. Mention that only after QC approval and QA release can it be issued.

Behavioural and teamwork questions

1. 9

   Tell me about a time you had to follow a strict procedure even when you were in a hurry.

   Use a college lab or project example. Show that you chose to follow the method, documented properly, and communicated if time was short, rather than cutting corners.

2. 10

   Describe a time you found a mistake in your own work. How did you handle it?

   Be honest about the error, explain how you reported it immediately, and what you learned. Emphasise that in pharma, hiding an error is far worse than making one.

3. 11

   How would you handle a disagreement with a senior analyst about a test result?

   Say you would present your data calmly, refer to the SOP or pharmacopoeial method, and escalate through the proper channel if needed. Show respect for hierarchy while protecting data integrity.

4. 12

   This role may involve shift work and repetitive testing. How do you stay accurate and motivated?

   Talk about routine and checklists, taking short breaks, and reminding yourself that every test affects patient safety. Mention that you find satisfaction in doing regulated work correctly.

HR and company fit

1. 13

   Why do you want to work as a QA Chemist in a pharma company rather than in a research lab?

   Focus on your interest in quality, compliance, and patient safety. Mention that you like structured work with clear specifications and that you want to build a career in GMP-regulated manufacturing.

2. 14

   What do you know about our company and the products we make?

   Research the company's therapeutic areas, manufacturing sites, and any quality certifications. For a company like FDC Limited, you could mention its presence in formulations and active ingredients, but keep it factual and brief.

3. 15

   Where do you see yourself in three to five years in a QC laboratory?

   Show a realistic path such as becoming fully independent in a section, learning more instruments, and taking on review or training responsibilities. Avoid saying you want to leave the lab soon.

4. 16

   Are you comfortable with the documentation and compliance load that comes with this role?

   Answer yes and give an example of your discipline with records, such as lab notebooks or project reports. Mention that you understand GDP and ALCOA+ are part of the job, not extra work.