Quality Assurance Expert

Job title:

Quality Assurance Expert

Company

Takeda

Job description

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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:This position is within the Quality organization at the Neuchâtel facility and is intended for the Quality Assurance department.Within this position, the QA Expert is responsible for compliance and quality oversight related to activities throughout the beginning of Takeda Neuchatel value stream process covering supplier quality management, supply chain & warehouse processes.How you will contribute:Supplier Quality ManagementLead the execution of supplier qualification, maintenance, and monitoring.Manage Supplier Notifications of Change (SNC), Quality Agreements, and supplier assessments including deviations and corrective actionsOversee supplier monitoring, Supplier Action Requests (SAR), and new supplier requests (NSR).Participate in on-site projects and conduct gap assessmentsParticipation in local GMP audits and external supplier auditsRelease activitiesInspection and Release of raw material and external BDSEnsure Release planning is up to dateFollow up on KPI of release of raw materialsEnsure activities associated with the archiving as requiredCompliance/Quality oversightAct as the Quality partner for QC Laboratory / Warehouse DepartmentExecute Takeda guidelines and Regulatory cGMP requirements in the respective Quality areaActs as Quality Representative in both routine and Takeda facility projects to support the quality system deployment and application in order to meet the current Regulatory RequirementsProvide feedback on projects and routine activities using proactive communicationExecute the Takeda internal facility GMP-Tour and participate to external audits as requiredSupport for regulatory agency inspection and internal audits, closure of observations/audit items and regulatory submissionsDeviationsAssess the deviations in term of acceptability to standard procedures and regulatory requirementsSupport all investigations related to CAPA process and complaint in the area of responsibilityChange ControlsReview and evaluate internal change requests, interfacility changes (IFCA) or external changes from suppliers (SNC) according to procedures, GMP requirements and licensesFollow the activities associated to the significant material changesReview and evaluate Material Qualification for chemicalsReview and evaluate Transportation Qualification for NE siteDocumentationPrepare, evaluate and approve new or revised documents (procedures/forms/specification etc)Ensure timely review and implementation of documentation for accuracy and compliancePropose continuous improvement of documentation in direct partnership with partnersWhat you bring to Takeda:University degree in Engineering, Biotechnology, Pharmacy and Quality ManagemenetFluent in English and French (C1 level)GMP Audit ExperienceHigh affinity to digital technologyDemonstrate the Takeda Values of Integrity, Fairness, Honesty, Perserverence as a natural way of working.Good knowledge of FDA, EMA, ICH regulations, Pharmacopeias and ISO Quality system standardsExecute the strategic direction and oversight pertaining to external auditing and supplier quality and material management to achieve sustained success for regulatory inspections and supply chain product qualityEnsure compliance with the global audit and specification policies, guidance, standards, procedures governing Quality Auditing and Supplier QualityExecute the Supplier Qualification program requirements per scheduleGood listener and communication skillsWhat Takeda offers you:– Competitive salaries.– Full accident coverage.– Participation in health insurance premiums.– Advantageous pension plans.– Subsidised meals.– Financial participation in employee sports activities.– Transport: support for local public transport passes, free parking, car sharing programme.– Takeda Neuchâtel offers its employees an attractive working environment and conditions. The well-being, safety, development and career advancement of its employees are at the heart of our vision and our Human Resources, Health, Environment and Safety policies.– Takeda Neuchâtel is an employer committed to its employees and to future generations.Learn more about Takeda Neuchâtel:With over 700 employees, Takeda Neuchâtel is one of the ten largest employers in the Canton of Neuchâtel and one of the leading biopharmaceutical production sites in Switzerland. Operating 24 hours a day, 7 days a week, the site employs a wide range of professionals trained in biotechnologies and their application in industrial production.With more than twenty nationalities, Takeda Neuchâtel offers an international, diverse and innovative working environment within a company that is firmly rooted and committed to its local ecosystem.Takeda Neuchâtel is certified as a training company by the Swiss State Secretariat for Economic Affairs. We train young apprentices in various fields such as laboratory quality control, logistics, IT and biopharmaceutical production.“Empowering our people to shine”:Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and job applicants without regard to skin colour, religion, gender, 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.Locations CHE – NeuchatelWorker Type EmployeeWorker Sub-Type RegularTime Type Full time

Expected salary

Location

Neuchâtel

Job date

Wed, 11 Dec 2024 23:04:41 GMT

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