QC Microbiology Executive (Supervisor)
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QC Microbiology Executive (Supervisor)Apply Now
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.
- 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
- 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.
LocationsGrange Castle, Ireland
Time TypeFull time
Job ID R0037360