"Project Associate I RA QA Job | ELEXES Medical Consulting Hiring Freshers | Pharma Duniya"

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"Project Associate I RA QA Job | ELEXES Medical Consulting Hiring Freshers | Pharma Duniya." (Project Associate I RA QA Job | ELEXES Medical Consulting Hiring Freshers) Introduction If you are a fresher or early-career professional aiming to build a strong career in Medical Device Regulatory Affairs and Quality Assurance , this opportunity can be a perfect starting point. ELEXES Medical Consulting Pvt. Ltd. has announced hiring for the position of Project Associate I – Regulatory Affairs & Quality Assurance (RA/QA) . This role is specially designed for fresh graduates and candidates with up to 6 months of experience who want hands-on exposure to global medical device regulations , including US FDA, EU MDR, CDSCO, Health Canada , along with ISO 13485 quality systems . The position offers real project experience under expert mentorship, making it ideal for long-term growth in the medical device regulatory domain. About The Company – ELEXES Medical Consulting Pvt. Ltd. EL...

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"Top 50 IPQA Interview Questions and Answers (Updated for Pharma Jobs 2026)"

"Top 50 IPQA Interview Questions and Answers – Pharma Duniya"




(Top 50 IPQA Interview Questions and Answers)




Introduction

In-Process Quality Assurance (IPQA) is one of the most important roles in pharmaceutical manufacturing. Whether you are a B.Pharm fresher, M.Pharm graduate, or an experienced QA professional, cracking an IPQA interview requires strong knowledge of GMP, documentation, deviations, BMR, audits, and compliance.

In this article, Pharma Duniya brings you the Top 50 IPQA Interview Questions and Answers, specially designed for pharma company interviews. These questions are commonly asked in tablet, capsule, injectable, syrup, API, and OSD manufacturing plants.


What is IPQA? (Quick Overview)

IPQA (In-Process Quality Assurance) ensures that pharmaceutical manufacturing activities are carried out as per approved procedures, GMP guidelines, and regulatory requirements during production and packing.

IPQA acts as a bridge between production and quality.


Top 50 IPQA Interview Questions and Answers


1. What is IPQA?

Answer:
IPQA stands for In-Process Quality Assurance. It ensures that manufacturing and packing processes comply with GMP and approved procedures during operations.


2. What is the role of IPQA in pharma?

Answer:
IPQA monitors in-process activities, performs line clearance, checks BMR entries, handles deviations, and ensures GMP compliance.


3. Difference between QA and IPQA?

Answer:
QA is a broad quality system, while IPQA specifically focuses on shop-floor activities during manufacturing and packing.


4. What is Line Clearance?

Answer:
Line clearance ensures that the production or packing area is free from previous product, documents, and materials before starting a new batch.


5. Why is Line Clearance important?

Answer:
It prevents mix-ups, cross-contamination, and documentation errors, ensuring patient safety.


6. What is BMR?

Answer:
BMR (Batch Manufacturing Record) is a controlled document that records complete manufacturing details of a batch.


7. What checks does IPQA perform in BMR?

Answer:

  • Correct entries
  • Signatures & dates
  • Yield calculations
  • Process parameters
  • Deviations, if any

8. What is BPR?

Answer:
BPR (Batch Packing Record) records all activities related to packing of the finished product.


9. What is GMP?

Answer:
GMP (Good Manufacturing Practices) are guidelines ensuring consistent product quality and safety.


10. What is Deviation?

Answer:
Deviation is any departure from approved procedures, specifications, or standards.


11. Types of deviations?

Answer:

  • Planned deviation
  • Unplanned deviation
  • Critical, Major, Minor deviations

12. What is CAPA?

Answer:
CAPA stands for Corrective and Preventive Action to prevent recurrence of deviations.


13. What is Change Control?

Answer:
A documented system to manage changes in process, equipment, material, or documents.


14. What is In-process Check?

Answer:
Checks performed during manufacturing like weight variation, hardness, thickness, pH, fill volume, etc.


15. What is Yield?

Answer:
Yield is the ratio of actual output to theoretical output.


16. What is Reconciliation?

Answer:
Verification of issued, used, rejected, and returned quantities of materials.


17. What is SOP?

Answer:
SOP (Standard Operating Procedure) gives step-by-step instructions to perform activities consistently.


18. What is Cross Contamination?

Answer:
Unintended contamination of one product with another product or material.


19. What is Data Integrity?

Answer:
Data Integrity ensures data is ALCOA+ compliant (Attributable, Legible, Contemporaneous, Original, Accurate).


20. What is ALCOA?

Answer:
ALCOA stands for Attributable, Legible, Contemporaneous, Original, Accurate.


21. What is Hold Time Study?

Answer:
Study to establish maximum holding time for materials or intermediates without quality impact.


22. What is In-process Rejection?

Answer:
Material rejected during manufacturing due to non-compliance.


23. What is OOS?

Answer:
Out of Specification result during testing.


24. What is OOT?

Answer:
Out of Trend result that shows abnormal trend though within specification.


25. What is IPQA Sampling?

Answer:
Collection of samples during manufacturing or packing for QC testing.


26. What is Environmental Monitoring?

Answer:
Monitoring of temperature, humidity, and microbiological conditions.


27. What is Audit?

Answer:
Systematic examination to ensure GMP compliance.


28. Types of audits?

Answer:

  • Internal audit
  • External audit
  • Regulatory audit

29. What is USFDA?

Answer:
United States Food and Drug Administration regulates drugs for the US market.


30. What is WHO GMP?

Answer:
Guidelines issued by WHO for pharmaceutical manufacturing quality.


31. What is Batch Release?

Answer:
QA approval to release a batch after reviewing all documents.


32. What is Critical Process Parameter?

Answer:
Parameter that directly affects product quality.


33. What is In-process Control Chart?

Answer:
Graphical representation of process performance.


34. What is Annexure?

Answer:
Supporting document attached to SOP or record.


35. What is Material Traceability?

Answer:
Ability to trace materials from receipt to final product.


36. What is GMP Training?

Answer:
Training to educate employees about GMP practices.


37. What is Risk Assessment?

Answer:
Evaluation of potential risks to product quality.


38. What is FMEA?

Answer:
Failure Mode and Effects Analysis used in risk management.


39. What is Validation?

Answer:
Documented evidence that process consistently produces quality product.


40. Types of validation?

Answer:

  • Process validation
  • Cleaning validation
  • Equipment validation

41. What is Housekeeping?

Answer:
Maintaining cleanliness and organization of production area.


42. What is Label Reconciliation?

Answer:
Verification of issued, used, and destroyed labels.


43. What is QA oversight?

Answer:
QA supervision over manufacturing activities.


44. What is Change Impact Assessment?

Answer:
Evaluation of effect of change on quality, safety, and compliance.


45. What is Logbook?

Answer:
Record of equipment usage and cleaning.


46. What is GMP violation?

Answer:
Non-compliance with GMP guidelines.


47. What is Shop-floor QA?

Answer:
QA presence directly on manufacturing floor.


48. What is Critical Deviation?

Answer:
Deviation with direct impact on product quality or patient safety.


49. What documents IPQA reviews?

Answer:
BMR, BPR, SOPs, logbooks, deviation reports.


50. Why do you want IPQA role?

Answer:
Because IPQA allows hands-on involvement in manufacturing quality and GMP compliance.


Final Conclusion

IPQA is a high-responsibility and high-growth role in pharmaceutical companies. Preparing these Top 50 IPQA Interview Questions and Answers will significantly increase your chances of cracking QA/IPQA interviews in leading pharma companies.

Stay consistent, revise GMP concepts, and always focus on quality mindset.

Note: Pharma Duniya does not charge any money for job information.
Candidates are advised to verify details from the official company website.


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Recommended Pharma Career & Job Resources (Must Read)

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