Maintaining quality and validation capability through long-running programmes

Quality and validation workforce planning needs to look beyond the next project milestone. For pharmaceutical manufacturers in Ireland, the practical question is who will maintain the necessary capability as priorities, workloads and team members change.

A programme may have enough specialists to execute its current work but too little capacity for the reviews, decisions and follow-up activities that come next. Build the workforce plan around those responsibilities, then review it as the programme develops.

Start with the work that must continue

EU GMP Annex 15 takes a lifecycle approach to qualification and validation. Sections 1.1 to 1.3 address planning, suitably trained personnel and appropriate quality oversight throughout validation. Section 2.2 covers approval and authorisation of validation documents by the appropriate personnel defined in the pharmaceutical quality system. Read Annex 15.

For workforce planning, translate that framework into a practical view of the coming months. Identify the systems and workstreams that need continuing support, the decisions approaching and the specialist knowledge each depends on.

Include review and close-out work alongside execution. A list of protocols to complete is only part of the picture. Ask who will review the evidence, respond to comments and resolve outstanding actions under the site’s procedures.

Separate execution capacity from review capacity

Use a simple planning sheet for each workstream: expected output, due date, preparer, reviewer, approver and estimated time required. Confirm the roles with the site’s quality and programme leads before using the sheet to make resourcing decisions.

Check the same people across every workstream. If one specialist appears against several simultaneous reviews, discuss the competing commitments early. Agree which work can move, which needs additional support and which requires a decision from the programme owner.

As a management practice, consider a rolling review of the next four to six weeks. Track work awaiting review, approaching decisions and changes in availability. This is a suggested planning rhythm, not a GMP requirement or a universal staffing formula.

Make continuity a specific responsibility

EU GMP Chapter 2 addresses sufficient qualified personnel, clear responsibilities and appropriate deputies. It also calls for training suited to assigned duties, continuing training and records of that training. Read Chapter 2, particularly sections 2.1, 2.3 and 2.11.

Use these principles to challenge the workforce plan. Who can cover an absence? What needs to happen before that person can take on the work? Which responsibilities depend on knowledge held by one individual?

For each critical responsibility, agree a cover arrangement with the relevant site lead. Record the experience, training and authorisation needed, rather than assuming that someone with a similar job title is ready to step in.

Keep contract review dates visible alongside programme milestones. Where continuing support may be needed, arrange the discussion before the current engagement reaches its end. Confirm any extension through the appropriate commercial process; do not treat an informal conversation as an agreed commitment.

Build handover into the work plan

Plan a short, structured handover whenever responsibility changes. Allow time for the incoming specialist to understand both the current position and the reasoning behind it.

• Identify the current approved documents and where they are held.
• Summarise open actions, owners and decision dates.
• Explain unresolved questions and the relevant escalation route.
• Confirm access, training and permissions before allocating work.
• Arrange a discussion with the outgoing specialist where possible.

Use the site’s controlled systems for formal records. A handover summary should point people towards the authoritative information and should not become an alternative approval record. Ask the receiving owner to confirm any remaining gaps while support is still available.

Choose an engagement model around the continuing need

A sustained requirement for connected specialist capability warrants a different conversation from a defined, temporary increase in workload. Describe the expected duration, responsibilities, interfaces and review arrangements before selecting an engagement model.

Berkley’s Professional Service Engagements support long-tenure specialist teams within client programmes. Contingent Workforce Solutions support specialist contractor deployment. Specialist Placements cover individual roles across professional services, business operations and technology, where those capabilities are needed alongside the technical programme.

For quality and validation work, discuss the proposed arrangement with the site leadership and quality function. Document who directs the work, who reviews it and who holds the relevant approval authority. An engagement label does not define those responsibilities on its own.

Our guide to choosing a workforce engagement model explores these decisions. For a new facility expansion, see our separate guide to planning a CQV team.

Bring a clear brief to the next workforce discussion

Prepare a one-page brief covering the work that must continue, the review capacity needed, current coverage gaps and the next decision date. Use it to agree the immediate actions and the longer-term capability the programme needs to retain.

Berkley’s Life Science practice supports quality, validation, regulatory, manufacturing and project engineering requirements. Speak to our team about your workforce requirements, including the specialist capability and continuity your programme needs.