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QC Microbiology Executive (Supervisor)

Dublin, Ireland

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QC Microbiology Executive (Supervisor)

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Job ID R0037360 Date posted 06/01/2021 Location Dublin, Ireland

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Job Description

JOB PURPOSE:

The purpose of the role is to manage the Microbiology laboratory to support the aseptic manufacturing of Alofisel product at Takeda Ireland Ltd, Grange Castle. 

RESPONSIBILITIES:

  • Responsible for the overall management of the Microbiology laboratory supporting the manufacture of Alofisel product.
  • Establish and lead the Microbiology team supporting the technical transfer of Alofisel through to operation readiness: Method Transfer/Validation, Contamination control strategy, Aseptic training, Environmental Monitoring program, raw materials testing, product testing, in-processing testing, process validation and facility validation.
  • People manager responsible for recruiting, managing, training, development and performance reviews from project phase into sustaining production.
  • Responsible for the operation and inspection readiness of the Microbiology laboratory by ensuring the laboratory operates in compliance with current Good Laboratory Practice / Good Manufacturing Practice at all times.   Implement and maintain standards of GLP and analytical practice consistent with current regulatory expectations and Global Takeda standards.
  • Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
  • Manage the environmental monitoring to support the manufacturing of the Alofisel.
  • Lead and participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing.
  • Manage contract testing laboratories associated with microbiological testing
  • Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence.  Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP.
  • Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate, customer).
  • Actively lead and support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
  • Implement and maintain standards of safety to ensure a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe at all times.
  • Generate, implement and control of Microbiology annual budget for consumables, capital and headcount.
  • As required, act as designee for the QC Laboratory Manager in their absence.
  • Participate as required in global project teams relating to Microbiology and wider quality activities

GENERAL RESPONSIBILITIES:

  • Participate fully in all cross functional training initiatives.
  • Drive and promote the corporate values of Takeda-ism within the workplace.
  • Actively foster, in cooperation with other 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.
  • Develop and maintain excellent communication and collaboration between the Microbiology laboratory and other work areas
  • Other duties as required and directed by the Site Quality Head or other Officer appointed by the Board of Directors.

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0037360
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