Checklist: GxP Quality, CSV, and Validation Interview Preparation

This is a ready-to-use self-assessment checklist for a GxP quality, computer system validation, or validation interview. Work each item, mark yourself Ready, Gap, or N/A, and note what to review for every Gap. It is a preparation tool, so the “specimen” shows one candidate’s honest self-scoring, not a company record. Replace the <<FILL: ...>> notes with your own. This is general guidance to adapt, not legal or regulatory advice. It pairs with the article Interview Preparation for GxP Quality, CSV, and Validation Roles.

How to use this

Score honestly against the four things interviewers actually grade: technical correctness, risk thinking, decision discipline, and communication. Any item you cannot deliver cleanly out loud is a Gap, not a Ready. Close the Gaps before the interview; a half-remembered answer is worse than a clean “I would confirm the exact clause, but the principle is X.”

1. Foundations

#	Item	Ready / Gap / N/A	Review note
1.1	Define GxP and tie it to patient safety, not paperwork	`<<FILL>>`	`<<FILL>>`
1.2	Explain ALCOA+ with a concrete failure for at least two attributes	`<<FILL>>`	`<<FILL>>`
1.3	Distinguish QA from QC in one clean sentence each	`<<FILL>>`	`<<FILL>>`
1.4	Distinguish correction, corrective action, and preventive action	`<<FILL>>`	`<<FILL>>`

2. CSV and validation deliverables

#	Item	Ready / Gap / N/A	Review note
2.1	Walk the V-model and explain traceability both directions	`<<FILL>>`	`<<FILL>>`
2.2	Define URS, FS, DS, IQ, OQ, PQ and what verifies what	`<<FILL>>`	`<<FILL>>`
2.3	Critique a bad (untestable) requirement	`<<FILL>>`	`<<FILL>>`
2.4	Explain GAMP 5 categories 1, 3, 4, 5 (and that there is no category 2)	`<<FILL>>`	`<<FILL>>`
2.5	Explain what CSA changes without saying “no more test scripts”	`<<FILL>>`	`<<FILL>>`
2.6	Explain the RTM and how it scopes regression testing	`<<FILL>>`	`<<FILL>>`
2.7	Contrast a validation plan with a summary report	`<<FILL>>`	`<<FILL>>`
2.8	Handle a failed validation test without editing the expected result	`<<FILL>>`	`<<FILL>>`

3. Part 11, Annex 11, and data integrity

#	Item	Ready / Gap / N/A	Review note
3.1	State what Part 11 requires and name Annex 11 as its EU counterpart	`<<FILL>>`	`<<FILL>>`
3.2	Distinguish open and closed systems	`<<FILL>>`	`<<FILL>>`
3.3	Explain risk-based audit trail review	`<<FILL>>`	`<<FILL>>`
3.4	Handle “testing into compliance” as a DI event	`<<FILL>>`	`<<FILL>>`
3.5	Explain why shared logins break Attributable	`<<FILL>>`	`<<FILL>>`
3.6	Explain static versus dynamic records and true copies	`<<FILL>>`	`<<FILL>>`

4. Deviation, OOS, CAPA, and quality system

#	Item	Ready / Gap / N/A	Review note
4.1	Walk the two-phase OOS investigation	`<<FILL>>`	`<<FILL>>`
4.2	Distinguish deviation, OOS, and out-of-trend	`<<FILL>>`	`<<FILL>>`
4.3	Name a root cause method and avoid “operator error” as the stop point	`<<FILL>>`	`<<FILL>>`
4.4	Explain CAPA effectiveness verification	`<<FILL>>`	`<<FILL>>`
4.5	State the three stages of process validation	`<<FILL>>`	`<<FILL>>`
4.6	Distinguish qualification from validation	`<<FILL>>`	`<<FILL>>`
4.7	Describe ICH Q10 and pair it with Q9	`<<FILL>>`	`<<FILL>>`

5. Inspection and regulations

#	Item	Ready / Gap / N/A	Review note
5.1	Distinguish a Form 483 from a Warning Letter and outline a 483 response	`<<FILL>>`	`<<FILL>>`
5.2	Cite Part 11, Annex 11, OOS, Process Validation, ICH Q9/Q10, CSA without inventing clause numbers	`<<FILL>>`	`<<FILL>>`
5.3	Speak to common warning-letter themes without inventing statistics	`<<FILL>>`	`<<FILL>>`

6. Behavioral and closing

#	Item	Ready / Gap / N/A	Review note
6.1	Four STAR stories prepared (held a line, a mistake, team conflict, explaining to a non-expert)	`<<FILL>>`	`<<FILL>>`
6.2	Two or three strong questions to ask the interviewer	`<<FILL>>`	`<<FILL>>`
6.3	Can scale effort to risk in every technical answer	`<<FILL>>`	`<<FILL>>`
6.4	Can stay calm and hold a defensible position under push-back	`<<FILL>>`	`<<FILL>>`

Sign-off

Field	Entry
Candidate	`<<FILL>>`
Target role	`<<FILL>>`
Interview date	`<<FILL>>`
Items Ready / total	`<<FILL>>`
Top three Gaps to close	`<<FILL>>`

References

The article behind each item: Interview Preparation for GxP Quality, CSV, and Validation Roles. For depth on individual topics, follow that article’s cross-links to the ALCOA+, GAMP 5, Part 11, OOS, and process validation pages. Verify any regulation you plan to cite against the current source before the interview.

Filled specimen

One candidate’s honest self-score two days out, illustrative only.

#	Item	Ready / Gap	Review note
2.4	GAMP 5 categories	Ready	Solid; can name examples for each
2.5	What CSA changes	Gap	Keep saying “no more scripts”; re-read the CSA answer and the reallocation point
3.6	Static vs dynamic records	Gap	Fuzzy on true copy of a dynamic record; review before Thursday
4.3	Root cause	Ready	Have a fishbone example ready
6.1	STAR stories	Gap	Only two drafted; need the mistake and the non-expert story

Field	Entry
Candidate	J. Okoro
Target role	CSV Analyst II
Items Ready / total	24 / 32
Top three Gaps to close	CSA reallocation answer; true copy of a dynamic record; two more STAR stories

The value is in the honesty: the candidate flagged three specific, closeable gaps rather than assuming readiness, and gave each a concrete review action with a deadline.

How to adapt this checklist

Add or remove rows to match the specific role (validation engineer, CSV analyst, QA generalist, clinical QA).
For a senior role, weight the scenario and escalation items more heavily than the definitions.
Turn every Gap into a dated review task, not a vague intention.
Re-score the morning of the interview and read only your remaining Gaps.