Quality Compliance Analyst

Description Are you looking for a patient-oriented, innovation-driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a Quality Compliance Analyst.Takeda's presence in Ireland was established in 1997 and our Irish operations have played a key role in our global leadership in rare diseases, oncology and gastroenterology. Since beginning commercial operations, Takeda Ireland has grown in strength thanks to substantial investment in our people and industry-leading technology.How you will contribute: Preparation and revision of Annual Product ReviewsPreparation and revision of cGMP documentation within the overall Quality Department as required.Quality data management in SAP and XFP (MES)Preparation and review of customer, supplier and service agreementsTo assist in the investigation into non-conformances, participate in root cause analysis and carry out quality review of non-conformancesSupport the site Quality Management systems including; the Deviation and CAPA Management systems, Change Control system, Internal Auditing programs, GMP Training and the Vendor Management program.Participate in and facilitate continuous improvement projects as requiredSupport oversight of GMP processes (Pest control, contamination control, facility/utility monitoring/requalification etc)Support oversight of GxP processes (system data integrity, periodic and backup reviews)Member of the Self-Inspection and external audit planning TeamMaintaining/Improving the validation system within the companyPreparation, execution and review/oversight of validation lifecycle documents and associated deviations/NCRs for equipment, facility, utility, process, cleaning & computerized systems.Documentation and Learning Management System supportDrive and promote the corporate values of Takeda-ism within the workplaceOther duties as required and assigned from time to time by the Site Quality Head or any other officer appointed by the Board of DirectorsDrive and promote the corporate values of Takeda-ism within the workplaceParticipate fully in any cross functional training initiatives.Ensuring compliance with current industry regulations and guidelines relating to validationTo assist and advise the validation of new/existing systems and equipment and liaise with production/scheduling departments on validation issuesParticipation in maintaining Department KPIsGeneral Responsibilities:Participate fully in any cross functional training initiatives.Drive and promote the corporate values of Takeda-ism within the workplace.Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.Ensure timely completion of all SOP, reading, training and assessment.Other duties as required and directed by the Head of Quality Compliance or other Officer appointed by the Board of Directors.What you bring to Takeda:Third level qualification in a Science, Engineering or IT discipline.Good knowledge of Pharmaceutical Production & Packaging processes.At least 2 years experience working in a Quality role in a regulated environment is advantageousExcellent interpersonal and communication skillsStrong planning and organization skillsSolid Oral Dosage processing experience is highly desirableGood knowledge of GMP and validation regulations and guidelines is highly desirableA technical understanding of processes, equipment and computer systems is advantageousExperience in data integrity practices would be an advantageExperience/ Interest in IT/software systems is a benefit.Experience/ Interest in validation is a benefitAccurate, with a strong attention to detail and right first time.Excellent verbal and written communication skillsBe a self-starter who is motivated and innovativeStrong interpersonal and Communication skillsGood organizational skills.What Takeda can offer you: Competitive salary and performance-based bonusEmployer retirement plan contributionsEmployee Stock Purchase PlanRevenue approved profit share schemeEmployer funded income protectionEmployer funded private medical insurance with dependants’coverEmployer life insurance contributionsElectric charging points available at parking locationsEmployee Assistance ProgramWellbeing and engagement teamsTakeda Resource GroupsFlexible working arrangementsFamily friendly policies26 vacation days plus additional days for service milestonesCoaching and mentoringEducational programs and formal trainingDevelopment opportunities Humanitarian volunteering leave optionsSubsidized canteen Flexible employee funded options like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance DealsMore about us:Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines.Takeda Ireland wasestablished in 1997. Our story in Ireland is one of substantial growth, rapid change, and innovation.Over the past two years, Takeda Ireland has invested over €55 million in Ireland to develop our manufacturing sites. Solidifying our commitment in our people and contributing to the local economy.Takeda in Ireland has commercial operations, corporate services, and manufacturing facilities across four locations: Baggot St, Bray, Citywest, and Grange Castle. We have been certified as Top Employer for several consecutive years.How we will support you:Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, color, 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. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process.LocationsBray, IrelandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time