Top QA Interview Questions / Answers
1) What is QA in Pharmaceuticals?
Answer:
Quality Assurance ensures that each product manufactured meets predefined quality standards. QA focuses on preventing errors, establishing systems, SOPs, policies, and ensuring compliance with GMP & regulatory guidelines.
2) Difference Between QA and QC
| QA | QC |
|---|---|
| Prevents defects | Detects defects |
| System / SOP / Documentation focused | Lab Testing / Analysis focused |
| Proactive | Reactive |
| Ensures process correctness | Ensures product correctness |
3) What is GMP?
Answer:
Good Manufacturing Practices are guidelines to ensure consistent product quality, safety, and efficacy during manufacturing.
4) What is SOP?
Answer:
Standard Operating Procedure — A written and approved document describing how to perform a job/activity step-by-step to maintain consistency.
5) What is Change Control?
Answer:
A formal process for requesting and approving any change in equipment, methods, documents, or process to ensure product quality is not affected.
6) What is Deviation?
Answer:
Any unplanned and unintended event that deviates from approved procedures or expected results.
Types:
- Planned Deviation
- Unplanned Deviation
7) What is CAPA?
Answer:
Corrective and Preventive Action
- Corrective: Take action to remove the existing cause of deviation.
- Preventive: Actions to prevent future occurrence.
8) What is OOS (Out of Specification)?
Answer:
When test results fall outside the predefined acceptance criteria.
OOS Handling:
- Laboratory investigation
- Batch record review
- CAPA implementation
9) What is Line Clearance?
Answer:
A check performed by QA before manufacturing and packaging to ensure the line is clean, documents are correct, and previous product traces are removed.
10) What is Data Integrity?
Answer:
Ensuring data is:
ALCOA+ Principles:
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
- Complete, Consistent, Enduring, Available
11) What is Validation?
Answer:
Documented evidence that a process/equipment/method consistently produces desired output.
Types:
- Process Validation
- Cleaning Validation
- Method Validation
12) What is IPQA?
Answer:
In-Process Quality Assurance ensures real-time monitoring of manufacturing & packaging to ensure quality at every step.
Extra HR Question
Tell me about yourself (QA Profile)
Answer (Use This):
“I am a graduate in B.Pharm/M.Sc with experience/knowledge in GMP, documentation, line clearance, deviation handling, CAPA, and IPQA activities. I am detail-oriented and committed to maintaining quality standards in compliance with WHO-GMP & regulatory norms.”
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