Frequently asked questions for QC/QA manager level in pharma industry

Preamble: An interview is a very special occasion for every jobseeker. Usually everybody makes preparation above/below par as per his perception/IQ level. Among the crowd only few lucky guy cross the hurdle while others effort remains square one…!. Generally jobseekers are not aware of their coming viva-voce scruitinization criteria which results into a sure failure. Recruiters ask mostly what you have mentioned in your Resume. Following are the prototype questions that are frequently being asked in chronological order for Manager QC/QA level positions in API/Formulation industry. Generally there are three rounds that are conducted.

A. Preliminary Round/Telephonic round:

In this round a brief discussion is organised and formal/mini technical questions are being asked depending on case to case. This is also called filter Round. Maximum peoples fate is decided in this Round.

B. Technical Round: This is conducted vis a vis in front of a group of expert’s panel.

1. Tell me something about yourself/ How can we know about you?.

2. What’s Quality policy of your organization?.

3. How many peoples are reporting to you and to whom do you report?.

4. What’s the maximum team size of peoples you have handled?.

5. What can you do for us/ How can you help us?.

6. What is a Quality product?.

7. What’s OOS, OOT,OOE explain in detail ?.

8. What is 21 CFR?explain in detail specially part 11 and 58.

9.  Explain class I, II & III solvent with example and limit.

10. Explain stability zones and stability procedures.

11. Explain type of analytical validation/verification in detail.

12. Calibration procedure for HPLC,GC, FTIR,UV-vis spectrophotometer, Dissolution,
      Disintegration apparatus.

13. Explain ANDA and it’s procedure in India and USA.

14. Explain clean room and it’s classification as per Fed std 209(E), ISO 14644 and EU GMP.

15. Explain air lock system in detail.

16. Why/when to validate/verify a compendial/non compendial method.

17. What’s your current job responsibility?.

18. What were your responsibilities during FDA/GMP/other inspections?.

19. What is the training procedure in your organization?.

20. Explain L1,GLP/cGMP/ICH Quality guideline/Drug and Cosmetic act,  PIC/S, MHRA,
     ANVISA  etc Regulations.

21. Explain Deviation, CAPA and Change Control.

22. How will you develop analytical method for a new compound?.

23. Explain SOR, HPLC, GC, Surface area analyser/Particle size analyser Principle and operation
      procedure.

24. What’s Autoclave and Sterlity validation procedure?.

25. What are Gram positive and Gram negative bacteria?.

26. Explain Bioindicator, environmental monitoring, sterility procedures and trace elements.

27. What is Water system validation and cleaning validation procedures?.

28. What are 7 QC tools?.

29. What’s APR/PQR and BMR/BPR?.

30. What’s DMF and it’s filing procedure?.

31. What’s master validation plan and process validation?.

32. What is the complaint handling procedure in your organization?.

33. What’s drug recall give classification.

34. Explain Validation and operation of HVAC system .

35. What’s QBD, Quality risk management, HACCP,FTA,PK,PAT,HAZOP,FMEA?.

36. What is GAP analysis?.

37. What’s Quality management system in your organisation?.

38. What’s carryover in HPLC/GC and how will you control this?.

39. How will you perform the Qualification of an instrument.

40. Why do you want to leave your current organization?.

 C. HR Round:

If technical round is successful then this round is conducted. In this round  personal Questions are discussed and eventually bargaining on salary takes place. Upon successful mutual agreement offer letter is either issued immediately or later.