This is a ready-to-use form for defining what a GxP role actually is, beyond its title: what it decides, what it must escalate, what qualifies someone to hold it, and who backs it up. A job posting describes what a company is looking for; this form is the controlled record of what the role is authorized to do once someone is in it, and it is what an inspector reads if a decision made by that role is ever challenged. Replace every <<FILL: ...>> placeholder with your own specifics. A worked filled specimen follows the template. This is general guidance to adapt, not legal or employment advice.
Document control header
| Field | Entry |
|---|---|
| Document title | Role Qualification and Job Description: <<FILL: ROLE TITLE>> |
| Document number | <<FILL: FORM-ID, e.g. FORM-HR-QA-009>> |
| Version | <<FILL: version, e.g. 1.0>> |
| Effective date | <<FILL: effective date>> |
| Department / function | <<FILL>> |
| Document owner | <<FILL: role, e.g. Head of Quality Assurance>> |
1. Purpose
This form records the core purpose, decision authority, escalation limits, minimum qualifications, and required training curriculum for a specific GxP role, and identifies who covers the role when the incumbent is unavailable. It is the source document a hiring manager writes from, the reference a new hire’s training plan is built against, and the record that answers an auditor’s question, “what was this person actually authorized to decide?“
2. Fields
| Field | Format | Required | Who completes | When |
|---|---|---|---|---|
| Role title | text | Yes | Hiring manager | At role creation or revision |
| Reports to (title, not name) | text | Yes | Hiring manager | At role creation or revision |
| Grade / level | text | Yes | HR | At role creation |
| Core purpose (1 to 2 sentences) | text | Yes | Hiring manager | At role creation or revision |
| Core responsibilities | bulleted list | Yes | Hiring manager | At role creation or revision |
| Decision authority (what this role can approve, reject, or sign without further escalation) | text, scoped | Yes | QA co-sign | At role creation or revision |
| Escalation authority (what must go to the role above) | text | Yes | QA co-sign | At role creation or revision |
| Minimum education | text | Yes | HR | At role creation |
| Minimum experience | text | Yes | HR | At role creation |
| Required curriculum before independent performance | list or reference to training matrix | Yes | Training / QA | At role creation or revision |
| Backup / delegate when vacant or absent | name or role reference | Yes | Quality Head | At role creation and kept current |
| Signature specimen on file | Yes / No | Yes | QA / Document Control | Before first independent sign-off |
| Next scheduled review | date | Yes | Document owner | At issue |
3. Instructions
- State the core purpose in plain language, one to two sentences, answering “why does this role exist” rather than restating the job title.
- List core responsibilities as concrete activities, not aspirations; “reviews batch records for completeness before disposition” is usable, “ensures quality” is not.
- Write the decision authority as a scope, not a blanket statement: name the record types, systems, or product lines the person can act on alone, and the dollar, risk, or complexity threshold above which they cannot.
- Write the escalation authority as the mirror of the decision authority: exactly what must go up, and to whom by title.
- Set minimum education and experience as a floor, not a wish list; an inflated requirement that does not match how the role is actually staffed becomes its own inconsistency when questioned.
- Reference the training curriculum this role requires rather than repeating it here; see the role-based training curriculum matrix for the paired document.
- Name a backup before the role is filled, not after the incumbent is unexpectedly out; an unnamed backup is a single point of failure hiding in plain sight.
- Confirm a signature specimen is on file before the person signs anything independently; a decision signed before the specimen is captured cannot be reliably attributed later.
- QA co-signs the decision authority and escalation authority fields specifically, because a manager writing a job description alone can unintentionally grant authority the quality system was never designed to give that role.
4. Retention
Retain this form for the duration the role exists plus <<FILL: retention period, e.g. current version plus prior 2 versions or per records retention schedule>>, and retain every superseded version; a superseded authority statement is often exactly what an investigation needs to show what someone could validly decide on a given date.
5. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
6. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Author (Hiring Manager) | <<FILL>> | ||
| Co-signer (QA, decision authority) | <<FILL>> | ||
| Approver (Department Head) | <<FILL>> |
Filled specimen
Illustrative role, values invented.
| Field | Entry |
|---|---|
| Role title | QA Reviewer, Batch Disposition |
| Reports to | Head of Quality Assurance |
| Grade / level | QA II |
| Core purpose | Confirms executed batch records, deviations, and release testing results support a defensible disposition decision before a batch reaches the market. |
| Core responsibilities | Batch record review against the master record; deviation and change control cross-check against the batch; escalation of any open item that blocks disposition; documentation of the review outcome. |
| Decision authority | Approves batch record completeness and disposition-readiness for the oral solid dosage line, up to and including recommending release; does not independently release a batch with an open critical deviation. |
| Escalation authority | Any deviation classified major or critical, any OOS not yet closed, and any disposition where a second QA reviewer disagrees, escalate to the Head of Quality Assurance before disposition. |
| Minimum education | Bachelor’s degree in a life science, chemistry, or engineering discipline, or equivalent documented experience. |
| Minimum experience | 2 years in a GMP quality role, batch record review preferred. |
| Required curriculum | Good documentation practices, batch record review SOP, deviation management SOP, data integrity foundations, per the role-based training curriculum matrix. |
| Backup / delegate | <<FILL: Name>>, Senior QA Reviewer, covers during leave or vacancy. |
| Signature specimen on file | Yes, captured 2026-08-01 |
| Next scheduled review | 2027-08-01 |
The specimen shows a bounded authority statement: this reviewer recommends release on one product line and cannot independently override an open critical deviation, which is exactly the scope an investigator expects to see match what the disposition record for that reviewer actually shows.
Common inspection findings this form prevents
- A job description that claims broad authority (“responsible for quality of the site”) with no scope, so no one can say what the person was actually allowed to decide alone.
- A decision made by someone whose job description was never updated after a reorganization, so their documented authority does not match what they were doing at the time.
- No documented minimum qualification for a role that turns out, on inspection, to have been filled by someone without the stated background, with no risk assessment or waiver on file.
- A backup named informally in conversation but never in writing, so a planned absence becomes an undocumented gap in coverage.
How to adapt this form
- Build one of these per distinct GxP role, not per person; two people in the same role share one form, referenced by both their training records.
- Keep the decision authority language specific enough that a disposition, approval, or rejection can be checked against it directly.
- Update the form the same week a role’s scope changes, and route the change through the same approval as the original.
- Link each completed form to the person’s training record and to the delegation and signature authority log so authority, training, and current status are all traceable from one place.