Laboratory Business Systems Analyst

Job Description

This role will support the Quality Control SDWT/Hub for testing of incoming raw materials, in-process drug substance/drug product, final drug products, stability samples and environmental monitoring of the controlled manufacturing areas and utilities at the new single use multi-product biotech facility in Dunboyne, County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for our rare disease Patients in Takeda, a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide.

The overall responsibility for this role will be to support the Quality Control testing function, ensuring compliance with cGMP and corporate regulations. This is a critical role within the Quality organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for our patients.

The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.

The Laboratory Business System Analyst will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement

Responsibilities

This role is associated with the data management systems for instrument control in the laboratories, this includes but is not limited to Labware LES (LIMS + Execution System), Lonza MoDa and Waters Empower. Below activities are associated with these systems;

• Participates in defining user requirements
• Tests and validates the design
• Develops procedures and training documents
• Assist in the implementation at site
• Gather raw data for template building
• After vendor provided training will provide first line of support within their laboratories
• Empower superuser to build and maintain custom calculation builds and system maintenance
• Reviewing analytical data, analytical reports and performing peer reviews.
• Instrument qualification, maintenance and troubleshooting.
• Protocol generation– method verification/transfer.
• Providing training for team members.
• Following all relevant Standard Operating procedures.
• Ensuring strict adherence to site policies, GMP and environmental, health and safety regulations.
• Complies with all pertinent regulatory agency requirements.
• Execution and on time completion of required training activities.
• Conducts thorough data review to ensure completeness and accuracy of records.
• Reviews test results to ensure compliance with standards; reports any quality anomalies.
• Participates in Laboratory Investigations as required.
• Writes and revises control test procedures and SOPs as required.
• May interact with outside customers and global support teams or functional peer groups.
• Promotes and exhibits Takeda Values.
• Executing company policies.
• Ensuring self inspections are performed.
• Ensures new/revised quality system requirements are deployed to the Site.
• Manage Methods and Calculations on Category C Instruments

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.