GMP Quality Assurance Validation & Transfer Specialist

Takeda Pharmaceutical Co.; Dublin; Vor Ort; EUR 58.000 - 79.000; Vollzeit

Zusammenfassung

Takeda Pharmaceutical Co. at Grange Castle, Ireland, seeks a Quality Assurance Validation (QAV) Specialist to provide independent quality oversight for validation, qualification and technical transfer activities at a GMP site.

The postholder collaborates with Manufacturing, Quality Control, Engineering and Regulatory Affairs to support compliant and timely project delivery. Key responsibilities include overseeing technology transfers, validating protocols and reports, and ensuring that

Aufgaben

• 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.

Jobbeschreibung

Takeda Pharmaceutical Co. at Grange Castle, Ireland, seeks a Quality Assurance Validation (QAV) Specialist to provide independent quality oversight for validation, qualification and technical transfer activities at a GMP site.

The postholder collaborates with Manufacturing, Quality Control, Engineering and Regulatory Affairs to support compliant and timely project delivery. Key responsibilities include overseeing technology transfers, validating protocols and reports, and ensuring that