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QC Systems Executive (Analytical Services)

応募 後で応募 求人ID R0125587 掲載日 06/13/2024 Location:Wicklow, Ireland

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Job Description

QC Systems Executive (Analytical Services)

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 an important 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 manage them to assure compliance with applicable regulations and company procedures.
  • To maintain required documents, including SOPs, specifications, and forms for all QC computerised systems, 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 help implement functional area end-user requirements and enhancements.
  • Support major projects, quality plans and continuous improvement programmes within the QC department(s) and in other
  • To ensure the system static data is updated promptly to ensure compliance.
  • To identify report requirements for departments, to design\develop or help with design\development of reports.
  • To work with the LIMS/Empower users to ensure compliance across all user groups.
  • To deliver LIMS system training to LIMS Users and the functional area, and to maintain records.
  • To provide support to other business systems to the interface with LIMS/Empower, to help develop instrument integration and data acquisition.
  • To support validation activities (IQ, OQ, PQ), coordinating and 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.
  • Record any validation deviations using the LIMS Incident Management and Change Control
  • Prepare for and supporting external audits (HPRA, FDA, corporate, or client).
  • To collaborate with QC, QA and IT Departments in the performance of normal tasks.
  • To help maintain 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 in any training plans.
  • 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 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 support 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.
  • 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.
  • 1 years' experience as a LIMS system administrator (Desirable)
  • Have relevant instrumentation experience in a pharmaceutical or similar environment
  • Demonstrated experience managing projects

What Takeda can offer you:

  • Great compensation package 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 schedule, e.g., hybrid or shift work with shift allowance
  • Family friendly policies
  • 26 vacation days plus additional days for service milestones
  • Mentor
  • 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, 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 new ideas. 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
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