Analytical Services Executive, Bray, Takeda Pharmaceutical

Analytical Services Executive, Bray, Takeda Pharmaceutical

Details + Details -

  • Job type: Full time
  • Contract type: Permanent
  • Salary type: Monthly
  • Occupation: Analytical services executive

Location + Location -

  • Country: Ireland
  • Region: Wicklow
  • City: Bray
  • Address: Bray

Description + 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 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 Description Analytical Services ExecutiveAbout the role: The Analytical Services Executive is responsible for the implementation and management of laboratory systems to support the manufacture of our Cell Therapy product at Takeda Ireland Limited Grange Castle (TILGC).Observe needs, the Analytical Service Executive may assume responsibilities in any other work area of the TILGC Cell Therapy Quality Department. As with all site personal the Analytical Services Executive promotes a culture of Regulatory Compliance and Continuous Improvement within the Cell Therapy Quality department and across the TILGC site.Onsite work mode. How you will contribute: The responsibilities of the Analytical Services Executive include the following:To develop required documents including SOP's (Standard Operating Procedures), specifications, and forms for all QC computerised systems, with QC manager/ Head of Quality or designees.To facilitate dialogue/ support between the LIMS/ Empower vendors and the system users, to troubleshoot and resolve issues.Implement and validate test methods for the Cell Therapy Manufacturing facility.To review validation and data migration within protocols and reports.The loading of LIMS Static Data for all test methods.LIMS data management.Integrate all laboratory equipment and associated software to LIMS.Contribute to the design and implementation of quality systems in the Cell Therapy QC laboratories to comply with relevant current regulatory expectations.To identify and help implement functional area end-user requirements and enhancements.To deliver LIMS/ Empower system training to users and the functional area, and to maintain records.To identify report requirements for, to design/ develop or support design/ development of reports.To provide support to other business systems to the interface with LIMS/ Empower, to help develop instrument integration and data acquisition.To help with validation activities (IQ, OQ, PQ), coordinating or building multiple portions of systems validation, for example performance qualification.To ensure the system static data is updated promptly to ensure compliance.To work with the LIMS/ Empower users to ensure compliance across all user groups.To collaborate with QC/ QA, IT and Manufacturing Operations departments in the performance of normal duties.To manage the investigation into any non-conformance, accident or other abnormal occurrence.Maintain standards of safety to guarantee a safe working laboratory.Support major projects, quality plans and continuous improvement programmes within the department(s) and in other departments.To highlight and implement new technologies in QC area.Ensure data integrity guidelines are implemented and observed, for QC-based systems.Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.Implement efficiency improvements in Quality Department on a continuous improvement basis and participating in site projects.Communication and liaison with Laboratory End-users on issues, providing support to others.General Responsibilities: Participate in any training plans. Promote the partner values of Takeda-ism within the workplace.Foster, in cooperation with other 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.What you bring to Takeda: Minimum of 5 years' experience in the Pharmaceutical/ Biologics industry.Practical experience working in a GMP laboratory (minimum 3 years).Practical experience working with LIMS as data input or reviewer (minimum 2 years).Minimum of a BSc Degree (life science).Work with Labware Version 7 however, not essential.Experience of in the QC Biologics and aseptic manufacturing.Cell Therapy (ATMP's) would be advantageous.Experience writing SOP's/ validation protocols.Excellent knowledge of good Manufacturing Practice as descried in current FDA & EMEA regulations for aseptic manufacturing, ATMP and Biologic.Experience with computerised systems.Experienced in technical writing.Project management.What 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 programs. Takeda is a patient-focused company to 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, 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.Locations Grange Castle, Ireland Worker Type Employee Worker Sub-Type RegularTime Type Full time

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Presented By: Takeda Pharmaceutical