QA Operations Specialist ( FTC 18 Months)

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Job Description

About the Role:

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. Acting as the QA Subject Matter Expert (SME), you will collaborate cross-functionally with technical, manufacturing, regulatory, and quality teams to ensure quality is embedded throughout the lifecycle of the technical transfer process.

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.

• 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).
• Foster a culture of safety, compliance, and continuous improvement.
• Lead by example in timely completion of training, documentation, and SOP adherence.
• Participate in and contribute to internal and external audits, safety initiatives, and cross-functional projects.

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.

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.

If you are interested in this opportunity, we look forward to receiving your application via our online tool!

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time