QA Validation & GMP Compliance Specialist

Takeda; Dublin; On-site; EUR 58,000 - 79,000; Full time

Job summary

The Quality Assurance Validation (QAV) Specialist at Takeda provides independent quality oversight for validation, qualification and technical transfer activities at our GMP manufacturing site in Grange Castle, Ireland. You will assess transfer readiness, review validation protocols, and ensure processes remain in a validated state, working closely with Manufacturing, Quality Control and Engineering.

This fixed-term, full-time role requires strong analytical thinking, documentation discipline

Responsibilities

• Provide QAV oversight for technology and technical transfers of products, processes, analytical methods and manufacturing knowledge into or between GMP sites.
• Review and approve transfer plans, protocols, risk assessments, acceptance criteria, reports and associated change controls.
• Assess transfer readiness, including gaps in process knowledge, facilities, equipment, utilities, analytical methods, documentation, training and material supply.
• Provide QAV oversight for process validation and verification activities, including process performance qualification (PPQ), continued process verification and lifecycle management.
• Review and approve validation protocols and reports, ensuring that the scientific rationale, sampling plans, acceptance criteria, deviations and conclusions are clear and supported by evidence.

Job description

The Quality Assurance Validation (QAV) Specialist at Takeda provides independent quality oversight for validation, qualification and technical transfer activities at our GMP manufacturing site in Grange Castle, Ireland. You will assess transfer readiness, review validation protocols, and ensure processes remain in a validated state, working closely with Manufacturing, Quality Control and Engineering.

This fixed-term, full-time role requires strong analytical thinking, documentation discipline