Quality Compliance Analyst
Wicklow, LeinsterAt 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.
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Job Description
Are you looking for a patient-oriented, innovation-driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a Quality Compliance Analyst.
Takeda's presence in Ireland was established in 1997 and our Irish operations have played a key role in our global leadership in rare diseases, oncology and gastroenterology. Since beginning commercial operations, Takeda Ireland has grown in strength thanks to substantial investment in our people and industry-leading technology.
How you will contribute:
Preparation and revision of Annual Product Reviews
Preparation and revision of cGMP documentation within the overall Quality Department as required.
Quality data management in SAP and XFP (MES)
Preparation and review of customer, supplier and service agreements
To assist in the investigation into non-conformances, participate in root cause analysis and carry out quality review of non-conformances
Support the site Quality Management systems including; the Deviation and CAPA Management systems, Change Control system, Internal Auditing programs, GMP Training and the Vendor Management program.
Participate in and facilitate continuous improvement projects as required
Support oversight of GMP processes (Pest control, contamination control, facility/utility monitoring/requalification etc)
Support oversight of GxP processes (system data integrity, periodic and backup reviews)
Member of the Self-Inspection and external audit planning Team
Maintaining/Improving the validation system within the company
Preparation, execution and review/oversight of validation lifecycle documents and associated deviations/NCRs for equipment, facility, utility, process, cleaning & computerized systems.
Documentation and Learning Management System support
Drive and promote the corporate values of Takeda-ism within the workplace
Other duties as required and assigned from time to time by the Site Quality Head or any other officer appointed by the Board of Directors
Drive and promote the corporate values of Takeda-ism within the workplace
Participate fully in any cross functional training initiatives.
Ensuring compliance with current industry regulations and guidelines relating to validation
To assist and advise the validation of new/existing systems and equipment and liaise with production/scheduling departments on validation issues
Participation in maintaining Department KPIs
General Responsibilities:
Participate fully in any cross functional training initiatives.
Drive and promote the corporate values of Takeda-ism within the workplace.
Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
Ensure timely completion of all SOP, reading, training and assessment.
Other duties as required and directed by the Head of Quality Compliance or other Officer appointed by the Board of Directors.
What you bring to Takeda:
Third level qualification in a Science, Engineering or IT discipline.
Good knowledge of Pharmaceutical Production & Packaging processes.
At least 2 years experience working in a Quality role in a regulated environment is advantageous
Excellent interpersonal and communication skills
Strong planning and organization skills
Solid Oral Dosage processing experience is highly desirable
Good knowledge of GMP and validation regulations and guidelines is highly desirable
A technical understanding of processes, equipment and computer systems is advantageous
Experience in data integrity practices would be an advantage
Experience/ Interest in IT/software systems is a benefit.
Experience/ Interest in validation is a benefit
Accurate, with a strong attention to detail and right first time.
Excellent verbal and written communication skills
Be a self-starter who is motivated and innovative
Strong interpersonal and Communication skills
Good organizational skills.
What Takeda can offer you:
Competitive salary and performance-based bonus
Employer retirement plan contributions
Employee Stock Purchase Plan
Revenue approved profit share scheme
Employer funded income protection
Employer funded private medical insurance with dependants’cover
Employer life insurance contributions
Electric charging points available at parking locations
Employee Assistance Program
Wellbeing and engagement teams
Takeda Resource Groups
Flexible working arrangements
Family friendly policies
26 vacation days plus additional days for service milestones
Coaching and mentoring
Educational programs and formal training
Development opportunities
Humanitarian volunteering leave options
Subsidized canteen
Flexible employee funded options like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance Deals
More about us:
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines.
Takeda Ireland wasestablished in 1997. Our story in Ireland is one of substantial growth, rapid change, and innovation.Over the past two years, Takeda Ireland has invested over €55 million in Ireland to develop our manufacturing sites. Solidifying our commitment in our people and contributing to the local economy.Takeda in Ireland has commercial operations, corporate services, and manufacturing facilities across four locations: Baggot St, Bray, Citywest, and Grange Castle. We have been certified as Top Employer for several consecutive years.
How we will support you:
Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, 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. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process.
Locations
Bray, IrelandWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeWorking at Takeda
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Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
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Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
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Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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