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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.

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