About the role:
This brief demands a commitment to the quality effort and the application of good analytical and technical skills.
Optional hybrid work model.
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.
* Administration on Computerised Systems.
* LIMS Static Data load for all test methods
* LIMS data management and maintenance
* Integration of all laboratory equipment and associated software to LIMS where possible.
* Contribute effectively to the design and implementation of quality systems in the QC laboratories to comply with relevant current regulatory expectations.
* To ensure the system static data is updated in a timely manner to ensure compliance.
* Change control owner related to any activities of new Instrument/Software Qualification.
* To identify report requirements for functional areas, to design\develop or assist in design\development of reports.
* To highlight and where necessary implement new technologies in QC area.
* Preparing for and supporting external audits (HPRA, FDA, corporate, client).
* To ensure the maintenance of all Clients within the QC Laboratories.
* To act as Data integrity SME for QC.
* 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.
* 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 assist in maintaining the validated status of all Instrumentation as situated in the QC Laboratories.
* To liaise with QC, QA and IT Departments in the performance of normal duties.
* Support major projects, quality initiatives and continuous improvement programmes within the QC department(s) and in other functional areas
* 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
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.
What you bring to Takeda:
* BSc. (minimum) in science or a related discipline.
* Practical experience working in a GMP laboratory (minimum 3 years).
* Practical experience working with LIMS and Empower as data input or reviewer (minimum 2 years).
* Working with Labware LIMS is preferred but not essential.
* Lab Equipment Management and Qualification desirable.
* System administration experience in a pharmaceutical or similar environment
* Demonstrated experience in managing projects
* Have good organisational, communication, interpersonal and report writing skills.
* Excellent organisational 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:
* Full Healthcare Cover - includes dependents
* Pension Scheme
* Attractive Bonus
* Subsidised canteen
* Parking facilities with electric car charging points
* Health & Wellness programs including onsite flu shots and health screenings
* Educational Assistance
More 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 that will 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.
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