Quality Assurance Validation (qav) Executive - Cell Therapy, Dublin, Takeda Pharmaceutical

Published 2022-09-20
Expires 2022-10-20
ID #1176340631
Quality Assurance Validation (qav) Executive - Cell Therapy, Dublin, Takeda Pharmaceutical
Ireland, Dublin, Dublin,
Published September 20, 2022

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Quality assurance validation (qav) executive - cell therapy

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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 DescriptionQuality Assurance Validation (QAV) Executive - Cell TherapyAbout the role: The Quality Validation Executive is responsible for ensure quality oversight on validation ensuring compliance with current industry regulations, guidelines and trends.The Quality Validation Executive will have specific and varying tasks as assigned by the Quality Systems and Compliance Manager.How you will contribute: Onsite work mode.Provide quality assurance validation support and approval (pre/post/approval) for qualification/validation lifecycle documentsSupporting Aseptic Processing Simulations(APS) with regard to generation of protocol, report and real time review APS during execution.Qualify premises, equipment and utilities;Including aseptic processing systems oversight (media fill, VHP validation, Environmental Monitoring)Computer system qualification.Laboratory equipment validation.Process validation.Perform quality assurance assessments relating to validation requirements, non-conformance, impact assessments, root cause analysis and implementation of CAPA found during CQV activities and requalification activities.Provide quality assurance validation support for Steam in Place (SIP) of buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains & autoclave loads.Responsible, with management support, for providing oversight of quality activities associated with the Quality records, MES, LIMS, SOPs.This role must ensure interaction the Operations, Engineering and CQV functions together with major such as Artwork, Supply Chain, QC, IT, QPs to ensure the reliable delivery of quality, safe, product to patients.Provide validation position on related topics and strategy and prioritise qualification activities following the project schedules.Be a Quality subject matter expert for in process validation which will be performed against global corporate SOP/HPRA /FDA/EMEA requirements.Ensure GMP compliance for validation deliverables related to site and capital projects (Compliance, Improvement, Technology Transfers) including requirements definition, specification, qualification, process validation and change management.Provide Quality expertise for the development (or modification phases) of manufacturing facility, equipment/systems, Material Qualification, Process Validation and Automated System and Computerised System.Approve and help define the process development strategies and ensure linkage with PPQ strategy deployment.Provide support during internal and agency inspections, Annual Product Quality Review and performing quality assessment for engineering changes.Participate in other projects as directed by the Head of Quality (Operations)General Responsibilities:Participate in any training plans.Guide and promote the corporate values of Takeda-ism within the workplace.Foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an necessary part of the business.Ensure that Accident Reports / Near Miss Forms are completed promptly after an event.Ensure completion of all SOP, reading, training and assessment.Other tasks and directed by the relevant Manager or other Officer appointed by the Board of Directors.What you bring to Takeda: Bachelor's degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline.Experience working in regulated environment with exposure in regulations and guidance's – GMP, CGMP, GAMP, 21 CFR Part 11.3 years of experience commissioning, qualification, and validation activities in a regulated environment.Technical knowledge of validation/ verification, quality systems and regulatory requirements.7 years working within quality in the pharmaceutical industry.4 years validation experience.3 + years of experience in QA technical role.Experience of sterile/biologics manufacture is necessary.Knowledge of relevant computer packages e.g. Trackwise, SAP, Tracelink and documentation systems.Experience working with ATMP is desirable.Knowledge of Good Manufacturing Practice for Advanced Therapeutic Medical Product (ATMP).with well-structured communication and presentation ability to audience levels.Be, flexible, organised and a good team player based on departmental and site requirementsWhat Takeda can offer you:Full Healthcare Cover - includes dependentsPension SchemeAttractive BonusSubsidised canteenParking facilities with electric car charging pointsHealth & Wellness programmes including onsite flu shots and health screeningsEducational AssistanceMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programmes. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Empowering our people to shine:Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.LocationsGrange Castle, IrelandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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    Dublin (, locally ; Irish: Baile Átha Cliath [ˈbˠalʲə aːhə ˈclʲiə; ˌbʲlʲaː ˈclʲiə]) is the capital and largest city of Ireland. Situated on a bay on the east coast, at the mouth of the River Liffey, it lies within the province of Leinster. It is bordered on the south by the Dublin Mountains, a part of the Wicklow Mountains range. It has an urban area population of 1,173,179, while the population of the Dublin Region (formerly County Dublin) as of 2016 was 1,347,359. The population of the Greater Dublin Area was 1,904,806 per the 2016 census.There is archaeological debate regarding precisely where Dublin was established by the Gaels in or before the 7th century AD. Later expanded as a Viking settlement, the Kingdom of Dublin, the city became Ireland's principal settlement following the Norman invasion. The city expanded rapidly from the 17th century and was briefly the second largest city in the British Empire before the Acts of Union in 1800. Following the partition of Ireland in 1922, Dublin became the capital of the Irish Free State, later renamed Ireland. Dublin is a historical and contemporary centre for education, the arts, administration and industry. As of 2018 the city was listed by the Globalization and World Cities Research Network (GaWC) as a global city, with a ranking of "Alpha −", which places it amongst the top thirty cities in the world.

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