Quality Assurance Validation Executive Dublin, Leinster Category: Quality

Job description

Please be aware of identity thieves actively posing as Takeda employees or recruiters posting Takeda-branded jobs online to steal personal information from job seekers. We care about your privacy and candidate experience. Learn more about how to spot fraudulent messages here. Our application process will be unavailable for scheduled maintenance from Saturday , August 1 at 5:00 AM ET through Sunday, August 2 at 4:00 AM ET . To be notified when applications are available again, please share your contact information here. --> Skip to main content Job Posting Find jobs for Location Radius Quality Assurance Validation Executive Dublin, Leinster Apply Now Job ID R0192706 Category Quality Subcategory Quality Business Unit Global Quality Job Type Full time By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. 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. For information about our benefits, please click here . Worker Type Employee Worker Sub-Type Fixed Term (Fixed Term) Time Type Full time Apply Now Share this job Facebook Xing LinkedIn Email Related content Learn more Frequently Asked Questions Learn more Healthcare for all Learn more How We Partner Learn more Innovators in Science Award Winners Learn more Luck is not a strategy Learn more Takeda Unveils Newly Renovated Cambridge Building Learn more Our Commitment to the Planet Learn more Our Products Learn more Our R&D Pipeline Learn more Patient Story: Rosie Learn more Putting Patients First Learn more Sustainable Value Report 2023 Learn more Takeda Global Headquarters Learn more Informiere dich über Stellenangebote Takedas Produktionsstandort Learn more Takeda in the US Learn more Takeda’s Global CSR Program Learn more The History of Takeda Learn more Values and Corporate Governance Learn more Takeda Manufacturing - 2021 Facilities of the Year Learn more Takeda Acquires Adaptate Therapeutics Learn more BioLife Plasma Services Learn more Biotech Site in Covington, GA Learn more Takeda’s Position on Climate Change Learn more <li class="js-hub-item hub-content__item showing-by-filter showing-by-load" data-hub-read-time="" data-hub-origin="False" data-hub-title="Corporate Responsibility" data-hub-meta-title="" data-hub-meta="" data-hub-url="jobs.takeda.com/" data-hub-isfallbackpage="False" data-hub-order="0