CMB QA Specialist
CMB QA SpecialistJob ID R0106944 Date posted Sep. 22, 2023 Location Wicklow, Ireland
Job Title: CMB QA Specialist
About the role:
To work within the Quality Assurance Department within the Regulatory Compliance Team to support with the timely management of incoming partner requests, outbound partner change assessments and to maintain regulatory, quality and compliance standards for divested and out licenced products and markets. To work in close collaboration with the Global CMB Team, being the single contact the TIL Bray site for all CMB related matters.
The brief requires a knowledge of Good Manufacturing Practice, current FDA & EMEA regulations for solid oral dosage pharmaceuticals for human use and a knowledge of manufacturing processes and packaging processes used in the pharmaceutical industry.
Optional hybrid work model.
How you will contribute:
- Manage incoming ad-hoc quality related requests and queries received from divested and out licenced partners at TIL Bray
- Manage all incoming change requests received from divested and out licenced partners at TIL Bray, ensuring change controls are raised by the relevant TILB departments
- Work with relevant TILB departments to ensure information required to address incoming partner requests, queries, change requests and TIL Bray documentation required to support HA queries and submissions is obtained and provided to the partners promptly
- Ongoing support and liaison with Global Regulatory Affairs (GRA) CMB, Contract Manufacturing Business (CMB) Quality, out licenced and divested parties to support regulatory submissions and renewals for divested and out licenced products
- Preparation, maintenance and revision of TIL Bray compliance statements for out licenced and divested markets within the QA Department
- Communicate with GRA CMB, out licenced and divestment partners on an ongoing basis and ensure local compliance to the regulatory dossiers is maintained
- Be a Subject Matter Expert (SME) on TILB change controls and API Site Change controls which impact TILB, for local regulatory compliance evaluations and complete related action tasks
- Support TILB change owners and API site change owners with identification of impacted TILB out licenced/divested partners and obtaining completed change assessment forms
- Manage divestment (MAT) related change controls, ensuring site action completion and implementation within the agreed/regulatory timelines
- Participate in continuous improvement projects
- Participate in any training plans.
- Improve and promote the corporate values of Takeda-ism within the workplace.
- Foster, in cooperation with other TILB staff, an ethos and culture of safety awareness where safety is accepted as an necessary part of the business. Ensure that Accident Reports / Near Miss Forms are completed promptly after an event.
- Embrace and demonstrate quality culture fundamentals in all tasks and interactions
- Ensure timely completion of all SOP, reading, training and assessment.
- Other responsibilities and directed by the Manager, QA or other Officer appointed by the Board of Directors.
What you bring to Takeda:
- Relevant third level qualification ((BSc, MSc, PhD), in a Science discipline.
- Regulatory Affairs Qualification is desirable.
- Minimum 5 years pharmaceutical experience in a Quality, Regulatory or Manufacturing Sciences role.
- Experienced in working with external parties.
- Experienced in investigational and technical writing skills.
- Work demonstrating support and respect to all departments
- Promote teamwork by helping foster a supportive and inclusive team atmosphere
What Takeda can offer you:
Full Healthcare Cover - includes dependents
Parking facilities with electric car charging points
Health & Wellness programs including onsite flu shots and health screenings
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
Worker Sub-TypeFixed Term (Fixed Term)
Time TypeFull time
Business Area Overview
At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma Collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.
Working at Takeda
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Recognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We Take Action by Focusing on Our Four Priorities
- Create an exceptional people experience
- Responsibly translate science into highly innovative, life-changing medicines and vaccines
- Protect our planet
- Unleash the power of data and digital
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