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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.

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  • 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.

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  • 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.

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QA Compliance Executive

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Job ID R0012424 Date posted 12/06/2019 Location Wicklow, Ireland

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Job Description

JOB PURPOSE:

This brief demands a thorough knowledge and understanding of pharmaceutical solid dosage validation procedures with technical understanding of process equipment and unit processes used therein.

RESPONSIBILITIES:
• Execution of site validation activities including:
 Qualification of equipment
 Computer system qualification
 Process validation
 Cleaning validation
 Qualification of utilities and facilities
 Requalification activities
• Maintaining/Improving the validation system within the company
• To assist the Compliance Specialist in the implementation and active participation in TIL Validation Procedures across the TIL plant.
• To review and evaluate FAT/FMEA/FS/URS/SDS/HDS/MR documents and report to ensure a good design basis is established for all validation studies
• To assist and advise the validation of new/existing processes and equipment and liaise with production/scheduling departments on validation issues
• To report and update the Compliance Specialist in Validation Activities across the plant as and when required.
• Preparation, review and execution of validation plans, CR/RA/DQ/IQ/OQ/PQ/PV/CQ protocols/reports and associated deviations/NCRs for equipment, facility, utility, process, cleaning & computerised systems.
• Statistical review of validation data.
• Liaise with vendors, external consultants & TIL departments on validation issues
• Assist in the maintenance of TIL production, engineering and quality systems and to ensure that the Validation projects/activities are executed in a timely manner and in compliance with the overall TIL Quality Management System.
• Ensuring compliance with current industry regulations and guidelines relating to validation
• Participate in cross-functional training, and direct training of validation designees by maintaining and improving validation SOPs, forms and training manual.
• Participation in maintaining Validation 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 Manager, Compliance or other Officer appointed by the Board of Directors.

EDUCATIONAL REQUIREMENTS:  
• Third level qualification in a Science, Engineering or IT discipline.

RELEVANT EXPERIENCE:
• Good knowledge of Pharmaceutical Production & Packaging processes.
• At least 3 years experience working in a validation role in a regulated environment
• Excellent interpersonal and communication skills
• Strong planning and organization skills
• People management experience would be an advantage
• Solid Oral Dosage processing experience is highly desirable
• Good knowledge of GMP, validation regulations and guidelines is highly desirable
• A strong 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 analytical validation is a benefit.

SKILLS/COMPETENCIES:
• Strong documentation skills & attention to detail.
• Be a self starter who is willing to learn.
• Strong Interpersonal & communication skills.
• Problem solving capability.
• Good organisational skills.

Locations

Bray, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0012424

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