What a role map is not
A role map is orientation — not a job description, a competency framework, or a statement of what any employer expects of you.
You check that the company actually follows its own quality rules, and report honestly what you find — including when it is unwelcome.
You plan and conduct risk-based internal audits, document findings against a stated requirement rather than against preference, and verify that corrective actions actually worked — independently of the areas you audit. Independence is the control: an auditor reviewing work they contributed to is not performing an audit, whatever the report is called.
You are the organisation’s mirror — the independent check that keeps self-inspection honest before a regulator does it. The value of the function is measured by whether it finds things, and an audit programme that never reports a significant finding is evidence about the programme, not about the organisation.
YOUR NEIGHBOURHOOD, IN ONE CONNECTED SYSTEM
In the internal audit programme, independent of the areas you audit, across the whole quality system.
- The risk-based audit schedule
- Audit planning and scope definition
- CAPA commitments and effectiveness checks
- Management review and inspection readiness
- Independence and access to records and areas
- The audit programme and applicable requirements
- Auditee cooperation
- Management (for an honest view of the state of control)
- Quality Assurance (for CAPA inputs)
- Planning and conducting objective audits
- Documenting findings against requirements
- Verifying corrective-action effectiveness
- Fixing the findings — the area owns its CAPA
- Approving its own function’s work
- The audit-programme owner and the Quality Head
- For a critical finding or an obstruction of the audit
- Audit plans and reports
- Findings and CAPA requests
- Effectiveness-verification records
WHAT THIS ROLE CAN EVIDENCE · 1
Mapped to this role in the published registry. Nothing on this site assesses them yet, so this is what the standard says the work involves — never a claim about you.
A role map is Locate, moment 2 of 5: what surrounds your work, what you own, and what you escalate. It does not teach the practice or test it. Next is Learn — the Quality Assurance pathway, then Practise in a scenario, then what any of it evidences. Skip any of them — the order does not change.
ENTERPRISE CAPABILITIES YOU WILL ENCOUNTER
The regulations and standards this pathway anchors on. SPEQ decodes and cites each one; the authoritative text lives at the official source.
- 21 CFR Part 211Current Good Manufacturing Practice for Finished PharmaceuticalsFDA · last revised 2023-04-01
- ICH Q9(R1)Quality Risk ManagementICH · last revised 2023-01-18
- ICH Q10Pharmaceutical Quality SystemICH · last revised 2008-06-01
- ISO 9001:2015Quality Management Systems — RequirementsISO · last revised 2015-09-15