QA Validation Lead: GMP Transfers & PPQ Oversight

Takeda Pharmaceutical Co.; Dublin; Presencial; EUR 58.000 - 79.000; Jornada completa

Descripción de la vacante

Takeda Pharmaceutical Co. is seeking a Quality Assurance Validation (QAV) Specialist at Grange Castle, Ireland.

The role provides independent quality oversight for validation, qualification and technical transfer activities at a GMP-regulated manufacturing site, ensuring plans, risk assessments and documentation are properly approved and that processes remain validated. You will collaborate with Manufacturing, Quality Control, Engineering, Technical Operations and Regulatory Affairs to support

Responsabilidades

• 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.

Descripción del empleo

Takeda Pharmaceutical Co. is seeking a Quality Assurance Validation (QAV) Specialist at Grange Castle, Ireland.

The role provides independent quality oversight for validation, qualification and technical transfer activities at a GMP-regulated manufacturing site, ensuring plans, risk assessments and documentation are properly approved and that processes remain validated. You will collaborate with Manufacturing, Quality Control, Engineering, Technical Operations and Regulatory Affairs to support