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Qa operations specialist

Dublin
Takeda
Operations specialist
Posted: 13 October
Offer description

As a Quality Assurance Associate, you will play a critical role in ensuring the successful and compliant technical transfer of API and Drug Substance intermediate into commercial manufacturing at Takeda Ireland Limited.
You will provide QA input of all quality-related activities, ensuring alignment with current Good Manufacturing Practices (cGMP), regulatory expectations, and corporate quality standards.
Key Responsibilities:
Technical Transfer QA Oversight
Coordinate QA activities associated with the technical transfer of API & intermediate, including review of technology transfer protocols, validation plans, and associated documentation.
Provide quality input and decision-making support during process performance qualification (PPQ), cleaning validation, method transfer, and comparability assessments.
Serve as a QA contact for transfer-related investigations, ensuring timely closure of deviations and robust root cause analysis with appropriate CAPAs.
Documentation and Batch Review
Review and approve executed batch manufacturing records, cleaning records, and analytical data.
Review and approve master batch records, validation protocols/reports, and other GMP-controlled documents associated with the product lifecycle.
Quality System Support
Oversee and support QMS elements relevant to the transfer project, including change controls, CAPAs, deviations, risk assessments, and quality agreements.
Collaborate with global QA and regulatory functions to ensure alignment with Takeda's global quality strategy.
Inspection and Audit Readiness
Support regulatory and partner audits relating to TAK-279 technical transfer, acting as QA representative during inspections and ensuring readiness of documentation and systems.
Drive proactive inspection readiness by ensuring data integrity, timely documentation, and audit trail compliance.
Continuous Improvement and Leadership
Identify and implement quality and compliance improvements related to transfer activities and site-wide systems.
Champion Takeda's core values (Takeda-ism) and foster a culture of quality and compliance across cross-functional teams.
What You Bring to Takeda:
Bachelor's degree (minimum) in chemistry, biology, pharmacy, or a related life science discipline.
Postgraduate qualifications (e.g. MSc, QP eligibility) are an advantage.
Minimum 3–5 years' experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry.
Demonstrated experience in technical transfer, commercialisation, or new product introduction is an advantage.
Strong knowledge of GMPs, regulatory guidelines (e.g. EMA, FDA, ICH), and quality risk management principles.
Proven ability to manage complex cross-functional projects with minimal supervision.
Strong decision-making, problem-solving, and risk assessment capabilities.
Excellent communication and stakeholder management skills, with ability to influence across departments and at various levels of the organisation.
Proficient in writing and reviewing technical documentation, including validation reports and investigation summaries.
Skilled in using electronic quality systems (e.g. TrackWise, Veeva, LIMS).
What you can look forward to with us:
Competitive Salary: Including performance-based bonuses.
Retirement Plan: Employer contributions to your retirement plan.
Comprehensive Insurance: Employer-funded private medical insurance with dependants' cover, life insurance, and flexible options like dental insurance, partner life insurance, and serious illness protection.
Electric Charging Points: Available at parking locations.
Employee Assistance Program: Support for personal and professional challenges.
Wellbeing and Engagement: Dedicated teams to support your wellbeing.
Family-Friendly Policies: Supportive policies for a balanced work-life.
Generous Vacation: 26 vacation days plus additional days for service milestones and humanitarian volunteering leave.
Development Opportunities: Coaching, mentoring, educational programs, and formal training.
Subsidized Canteen: Enjoy meals at a reduced cost.
Flexible Benefits: Options like fuel card, bike to work, commuter ticket, and insurance deals.
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.
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