QA Responsible Person
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.
What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.
Life at Takeda
A Global Top Employer
Recognized for our culture and way of working, we’re one of only select companies to receive Top Global Employer® status for 2019.
At Takeda, your determination and energy, combined with our cutting-edge technology and global R&D, offers families and communities hope for Better Health and a Brighter Future.
Learn more about Manufacturing, Supply Chain, and Quality careers within our global biopharmaceutical company.
At Takeda, there is an unwavering commitment to putting patients first, and to creating a workplace that is underpinned by empowerment and focused on diversity, collaboration and steadfast values.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
QA Responsible PersonApply Now
- Provide leadership in the development of policy, process and organization to ensure compliant operations
- Perform all the duties and have all rights applicable to the Responsible Person in Ireland as per HPRA requirements
- Decide on all pharmaceutical activities in scope of the License
- Maintain locally the Quality Management System
- Provide direction to the organization for the activities falling under the responsibility and decision making mandated by HPRA
- Ensure all requirements to maintain the Wholesale Distribution License are met
- Provide expertise in Regulatory Compliance for the products manufactured and traded by Takeda
- Perform all the duties and have all rights legally applicable to the Responsible Person
- Accountable to ensure GxP related activities which support Takeda’s global trading of products are compliance and efficient.
- Ensure all requirements to maintain the Trade License of the Irish organization are met.
- Ensure that Quality Management System is fully implemented and maintained
- Ensure training on procedures to impacted parties
- Ensure necessary authorisations are in place to decide on all pharmaceutical activities and ensure safe and compliant processes of trading pharmaceutical products in foreign countries
- Review and approve relevant operational documents of GxP impact
- Manage inspections, corporate internal audits
- Manage self-inspections and external audits as needed
- Lead or support local, regional, global projects, as needed
- Ensure availability for management of critical events requiring pharmacovigilance, escalation and/or recall, decisions and/or support.
- Keep appropriate records and control of any delegated duties and ensure their visibility
- Accountable for decisions related to disposition of returned, recalled or falsified product
- Align with a broad global network of stakeholders, including management teams and business units operating with and on behalf of the Swiss Headquarter
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Meets qualifications to be an Industry Certified Responsible Person (RP) in Ireland
- Scientific Degree (preferably in Pharmacy)
- Minimum 5 years' experience in a Quality Assurance/Regulatory Compliance in the Pharmaceutical industry are essential
- GDP, distribution, warehousing and transportation experience
- Highly punctual, systematic, highly organized, & concise in communication
- Strong attention to details, ability to review & managing documentation
(Including transport temperature records, shipping documents. and related GDP documents, records etc.).
- Highly flexible, creative, and have strong desire to get results in complex & sometimes unpredictable environment
- Broad understanding of Supply Chain related topics as well as related risks and global regulatory implications Fluent English (written & oral), additional European languages are a plus
- International travel as required up to 30%
- Committed team player
- All applicants must hold a valid EU passport
Job ID R0004054