Commissioning, qualification and validation (CQV) contracts can cover very different work, even when the job titles match. For a pharmaceutical site in Ireland, ask for a written brief before agreeing your availability.
This checklist separates GMP qualification requirements from practical questions to agree with the recruiter and client. It is not a vacancy list, or legal or tax advice.
1. Define the qualification scope
Ask which systems are included, their current qualification status and the stages you will own. Get access to the validation master plan, or equivalent, and the project’s risk-based approach.
- Are you writing protocols, executing tests, reviewing evidence, or coordinating the whole package?
- Does the scope include design qualification, factory or site acceptance tests, installation, operational or performance qualification?
- Are process validation, cleaning validation or requalification included, or handled by another team?
Separate commissioning deliverables from qualification evidence. Under EU GMP Annex 15, qualification and validation need planned, documented activities and quality oversight. A job title alone does not define those responsibilities.
2. Check the documentation and approvals
Confirm who writes, executes, reviews and approves each deliverable. Ask whether approved procedures, protocols, acceptance criteria and necessary equipment records are ready.
Clarify how supplier evidence will be assessed and whether factory tests can support qualification. Annex 15 allows some tests to avoid repetition onsite when appropriately justified; reuse is not automatic.
- Who investigates deviations and approves protocol changes?
- What reports and authorisations are needed before the next qualification stage?
- Which training and document-system access must be completed before you can execute work?
A missing approval route can delay delivery just as much as missing equipment. Resolve it before committing to a completion date.
3. Agree the site arrangements
Confirm the exact site, expected onsite days, normal hours, shifts and vendor travel. Ask which execution tasks require physical attendance and which documentation tasks can be completed remotely.
Agree overtime approval and expenses before travel is booked. Check induction dates, access readiness and any required safety training. Annex 15 requires suitably trained personnel, but it does not set hybrid-working arrangements.
4. Put the commercial terms in writing
Identify the contracting party and who pays you. Confirm the start date, duration, rate, agreed hours and payment frequency. Do not assume the client’s project brief is your complete contract.
- Who approves timesheets, and what happens if that person is unavailable?
- What are the invoice deadline, payment terms and expense rules?
- How are extensions, early termination, notice and handover handled?
- What confidentiality, document ownership and insurance obligations apply?
These are practical contract checks, not qualification requirements. If your employment status or contractual obligations are unclear, get appropriate independent advice before signing.
A brief worth asking for
Request one written summary: system scope, deliverables, approval contacts, site attendance, rate, payment terms and start date. Compare that summary with your contract and resolve differences before accepting.
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Source and scope
The qualification guidance above draws on the European Commission’s EU GMP Annex 15: Qualification and validation, particularly sections 1–3. The site and commercial questions are practical checks, not claims about Irish employment law.