Quality Assurance Validation Executive

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

Job summary

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

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

Job Description

Objective / Purpose:

The Quality Assurance Validation (QAV) Specialist provides independent quality oversight and guidance for validation, qualification and technical transfer activities at a GMP-regulated pharmaceutical manufacturing site. The role ensures that activities are appropriately planned, risk

assessed, documented and approved, and that the resulting processes, equipment, facilities, utilities and systems are suitable for their intended use and remain in a validated state.

The postholder works closely with Manufacturing, Quality Control, Engineering, Technical Operations, Regulatory Affairs and external partners to support compliant and timely project delivery.

Key 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.

Locations

Grange Castle, Ireland

Base Salary Range:

€57,800.00 - €79,420.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time