Quality Compliance Specialist
Quality Compliance SpecialistJob ID R0090793 Date posted Mar. 13, 2023 Location Dublin, Ireland
Quality Compliance Specialist -
Experience working in sterile / aseptic manufacturing pharmaceutical facilities is essential
Location: Grange Castle
About the role:
The Quality Compliance Specialist is responsible for the coordination of compliance activities with the manufacturing area, and for varying duties as assigned by the Head of Quality Compliance.
Optional hybrid work model.
How you will contribute:
Becoming embedded in the TILGC P3 Cell Therapy facility as a Compliance Specialist.
Maintaining oversight of compliance with the ATMP guidelines within the cell therapy facility.
Ensuring GMP-impacting systems are maintained as per written procedures.
Becoming a key member of the TILGC audit / inspection teams during external cGMP audits and inspections, e.g., corporate audits and regulatory authority inspections.
Assisting in implementation of Global Standards and Procedures into the site Quality Management Systems.
Leading and participating in the P3 self-inspections, maintaining schedule adherence, and tracking actions.
Actively supporting the development and implementation of continuous improvements to the QMS.
Participating in Quality Risk Assessments periodic reviews.
Oversight and preparation of Key Performance Indicators to align with company and global quality objectives.
Assisting in and facilitating completion of deviation investigations as part of the site Deviation Management System, ensuring effective root cause analysis and appropriate CAPAs.
Assisting in and coordinating the timely completion of Annual Product Quality Reviews.
Driving and promoting the corporate values of Takeda-ism within the workplace.
Maintaining awareness of status of related regulatory / market submissions.
Assisting in oversight and management of key elements of the Quality Management System (QMS) on site, which includes but not limited to, Inspection Readiness, Quality Council, Complaint coordination and communications, Quality Risk Assessments, and Regulatory Compliance oversight.
Participating in projects as directed by the Head of Quality Compliance.
Becoming cross-trained in multiple quality systems.
Actively fostering, in cooperation with other TILGC staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
Ensuring that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
On time completion of all assigned trainings, and assessments.
Other duties as required and directed by the Head of Quality Compliance, or Site Quality Lead.
What you bring to Takeda:
Bachelor's degree in chemistry, biology or a related scientific discipline.
Experience working in sterile / aseptic manufacturing pharmaceutical facilities
A minimum of 4 years working within Quality in the pharmaceutical industry.
Thorough understanding of sterile / aseptic manufacturing guidelines, the Pharmaceutical Management Systems guidelines, cGMPS, EU / US / JP guidelines.
Lead Auditor training and experience leading internal audits
Knowledge of finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, process development, and manufacturing operations.
Excellent verbal and written communication skills.
Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements.
Work directly with other key departments to ensure compliance and productive working relationships.
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, color, 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.
LocationsGrange Castle, Ireland
Time TypeFull time
Business Area Overview
On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:
- Small Molecules
- Cell and Gene
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
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.
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- 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