cGMP Production & Labeling Lead

WEP Clinical Ltd; Dublin; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Group Private Medical Insurance

Group General Life Assurance

Group Critical Illness and Group In‑s

Salary sacrifice pension scheme

Enhanced maternity & paternity pay

Educational Assistance allowance

Paid volunteering day

Job summary

WEP Clinical Ltd in Ireland is seeking a cGMP Production Manager to lead hands-on production, packaging, and labeling activities while ensuring audit-ready operations. You will manage room setup, batch execution, documentation, and labeling controls, working with cross-functional teams across Global Supply Chain Operations.

The role requires deep knowledge of GMP/GDP standards, MBR/EBR control, and ERP-driven BOM management, with a focus on process optimization and global standardization

Qualifications

• 8 years of experience in cGMP secondary packaging and labeling in pharma or clinical supply.
• Strong knowledge of cGMP requirements and global pharma packaging standards.
• Experience with label design, artwork, MBR/EBR, and documentation with version control.

Responsibilities

• Execute and oversee GMP production activities, including room setup, batch execution, in-process checks, reconciliation, line clearance, and clean-down.
• Maintain production suites in a continuous audit-ready state, ensuring compliance with GMP, GDP, SOPs, and quality standards.
• Serve as a global production SME, providing real-time troubleshooting, escalation support, and technical guidance during operations.
• Verify readiness and compliance of materials, labels, packaging components, equipment, and documentation prior to batch execution.
• Create, review, and maintain MBRs and EBRs, ensuring accurate, timely, and compliant batch documentation.
• Develop, proof, issue, control, and reconcile label templates, artwork, and packaging layouts to meet regulatory, client, and protocol requirements.
• Partner with Project Management, Regulatory, and Quality to finalize packaging and labelling designs, layout drawings, samples, and client approvals.
• Maintain BOMs and related master data in ERP systems, ensuring accurate configuration, versioning, and updates.
• Support vendor coordination, sourcing decisions, and supplier qualification for packaging components, tooling, consumables, and equipment.
• Drive process optimization, change controls, system enhancements, and global standardization initiatives across Production and Global Supply Chain Operations.

Skills

Strategic thinking

Collaborative

Proactive

Adaptable

Strong problem-solving

Vendor & stakeholder management

Cross-functional collaboration

Tools

ERP systems

Job description

WEP Clinical Ltd in Ireland is seeking a cGMP Production Manager to lead hands-on production, packaging, and labeling activities while ensuring audit-ready operations. You will manage room setup, batch execution, documentation, and labeling controls, working with cross-functional teams across Global Supply Chain Operations.

The role requires deep knowledge of GMP/GDP standards, MBR/EBR control, and ERP-driven BOM management, with a focus on process optimization and global standardization