Takeda is a global pharmaceutical leader with more than 30,000 professionals working together across more than 70 countries. We have an unwavering dedication to put people first and we live our values of Takeda-ism: Integrity, Fairness, Honesty, and Perseverance. We are united by our more than 230-year legacy of research-based pharmaceuticals and our mission to strive toward Better Health and a Brighter Future for people worldwide through leading innovation in medicine.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.
The purpose of the role is to manage the Microbiology laboratory associated with the manufacture of Alofisel biologics product at Takeda Ireland Ltd, Grange Castle. The Microbiology laboratory is based in the P3 production building.
• Responsible for the overall management of the Microbiology laboratory supporting the manufacture of Alofisel biologics product.
• Ensure that the Microbiology laboratory is set up and 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.
• Develop and maintain excellent communication and collaboration between the Microbiology laboratory and other work areas.
• Supervise Microbiologists including training, recruitment, motivation, discipline and performance appraisal.
• 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 P3 environmental monitoring programme.
• Lead and participate in the technical transfer / validation of microbiological testing procedures.
• 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.
• Manage an effective laboratory documentation system. The Microbiology Executive will prepare, review and approve documents as required.
• 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 Manager in their absence.
• Participate as required in global project teams relating to Microbiology and wider quality activities
To further support and inspire our employees, our benefits include: Talent & Development Programme, Flexibility, Occupational Health & Wellness Programme, Company Events, Health Insurance, Pension, Paid Maternity/Paternity Leave, Educational Assistance Programme, Performance Related Bonus, Zero Absence Award, Onsite Parking, and Onsite Canteen.
Empowering Our People to Shine. Learn more at takedajobs.com.
Takeda Ireland Limited is an Equal Opportunities