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QA Executive - Ireland
Posted on : 22 October 2017
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Quality Assurance Executive in our Grange Castle API Manufacturing Site in Dublin 22
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 Quality Assurance Executive (API) is responsible for managing the Quality Assurance team associated with production of oral solid dosage product in the P1 (API) production facility at Takeda Ireland Limited Grange Castle (TILGC).
In accordance with business needs, the Quality Assurance Executive (API) may assume responsibilities in any other work area of the TILGC Quality Department.
The responsibilities of the Quality Assurance Executive (API) include the following:
• Management of the Quality Assurance team in the API production facility.
• Management of batch disposition and material status control activities associated with API.
• Management of review of Batch Manufacturing Records (BMRs).
• Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
• Management of the Change Control process associated with API, ensuring controlled implementation of all GMP related changes.
• Management of QA oversight of routine manufacturing, testing and relating activities to ensure ongoing cGMP compliance.
• Ensuring effective participation of the API Quality Assurance team in production and other site meetings.
• Implementation of Key Performance Indicators within the API Quality Assurance area to align with company and global quality objectives.
• Participation in the site Internal Audit programme.
• Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
• Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.
• Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement.
• Implementing efficiency improvements in Quality Dept. on a continuous basis and participating in site projects and initiatives.
• Communication and liaison with other TILGC departments on Quality issues (as required), providing guidance and support to others.
• Motivation, training, discipline and appraisal of Quality Assurance staff.
• Acting as a designee to the Quality Assurance Manager as required.
What Takeda Can Offer You
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 Employer