Job Information
Takeda Pharmaceuticals QC Systems Executive (Analytical Services) in Wicklow, Ireland
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Job 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 QC Systems Executive (Analytical Services).
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 :
To maintain the validated status of the LIMS/Empower systems and other relevant systems and to implement and manage them to assure compliance with applicable regulations as well as company policies and procedures.
To develop and maintain required documents, including SOPs, specifications, and forms for all QC computerised systems, in conjunction with QC Manager \ Site Quality Head or designees.
To facilitate dialogue\support between the LIMS/Empower vendors and the system users, to troubleshoot and resolve issues.
To identify and support the implementation of functional area end-user requirements and enhancements.
Support major projects, quality initiatives and continuous improvement programmes within the QC department(s) and in other functional areas
To ensure the system static data is updated in a timely manner to ensure compliance.
To identify report requirements for functional areas, to design\develop or assist in design\development of reports.
To work in conjunction with the LIMS/Empower users to ensure compliance across all user groups.
To deliver LIMS system training as appropriate to LIMS Users and\or the functional area, and to maintain adequate records.
To provide support to other business systems with respect to the interface with LIMS/Empower, to assist in developing instrument integration and data acquisition.
To assist in validation activities (IQ, OQ, PQ) as required, coordinating and\or executing various portions of system validation, for example performance qualification.
Execution and review of validation and data migration protocols and reports in compliance with Regulatory, GMP and GLP guidelines.
Recording of any validation deviations using the LIMS Incident Management and Change Control
Preparing for and supporting external audits (HPRA, FDA, corporate, client).
To liaise with QC, QA and IT Departments in the performance of normal duties.
To assist in maintaining the validated status of all Instrumentation as situated in the QC Laboratories.
To ensure the maintenance of all Clients within the QC Laboratories.
To act as Data integrity SME for QC.
General 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 Manager, QC or other Officer appointed by the Board of Directors.
Desirable but not essential:
To schedule a programme of Preventative Maintenance and Vendor Support for QC Instrumentation.
To provide Instrumental troubleshooting support.
To maintain all relevant support documentation concerning Instrumentation i.e. IQ, OQ, PQ, Calibrations and SOPs.
To assist in the sourcing and purchasing of new Instrumentation, where directed, ensuring that said Instrumentation is qualified according to applicable standards.
To ensure that all relevant Instrumentation is calibrated according to TIL procedures, in an accurate and timely manner.
To maintain the validated status of all Instrumentation as situated in the QC Laboratories.
What you bring to Takeda :
BSc. (minimum) in science or a related discipline.
Minimum of 3 - 5 years’ experience in a Quality Control laboratory or similar environment.
Minimum of 1 years’ experience as a LIMS system administrator (Desirable)
Have relevant instrumentation experience in a pharmaceutical or similar environment
Demonstrated experience in managing projects
Have good organisational, communication, interpersonal and report writing skills.
Excellent organisation skills.
Good decision making skills.
Will be proactive and flexible
Ability to work independently with minimum supervision.
Strong attention to detail.
What Takeda can offer you:
Competitive salary and performance-based bonus
Employer retirement plan contributions
Employee Stock Purchase Plan
Revenue approved profit share scheme
Employer funded income protection
Employer funded private medical insurance with dependants’cover
Employer life insurance contributions
Electric charging points available at parking locations
Employee Assistance Program
Wellbeing and engagement teams
Takeda Resource Groups
Flexible working arrangements, e.g., hybrid or shiftwork with shift allowance
Family friendly policies
26 vacation days plus additional days for service milestones
Coaching and mentoring
Educational programs and formal training
Development opportunities
Humanitarian volunteering leave options
Subsidized canteen
Flexible employee funded options like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance Deals
More 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 was established 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.
Locations
Bray, Ireland
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time