GMP QA Validation Lead - Tech Transfer & PPQ

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

Job summary

Takeda is seeking a Quality Assurance Validation (QAV) Specialist at Grange Castle, Ireland, to provide independent quality oversight for validation, qualification and tech transfer within a GMP environment.

You will collaborate with Manufacturing, QC, Engineering and Regulatory Affairs to ensure plans, risk assessments and approvals support compliant, timely project delivery and a validated state of systems, processes and equipment.

Responsibilities

• Provide QAV oversight for technology transfers of products, processes, and methods into or between GMP sites.
• Review and approve transfer plans, protocols, risk assessments, and change controls.
• Assess transfer readiness including gaps in process knowledge, facilities, equipment, and documentation.
• Oversee process validation activities, including PPQ and lifecycle management.
• Review validation protocols and reports ensuring rationale, sampling, acceptance criteria and evidence.

Job description

Takeda is seeking a Quality Assurance Validation (QAV) Specialist at Grange Castle, Ireland, to provide independent quality oversight for validation, qualification and tech transfer within a GMP environment.

You will collaborate with Manufacturing, QC, Engineering and Regulatory Affairs to ensure plans, risk assessments and approvals support compliant, timely project delivery and a validated state of systems, processes and equipment.