QA Operations Senior Specialist
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Job Description
About the role
The Quality Operations, Senior Analyst is responsible for ensuring the quality and integrity of processes and product outputs by defining, implementing, and monitoring activities, processes, and standards that meet internal quality expectations and regulatory requirements. The role supports quality assurance through auditing, monitoring, and evaluation of processes and outputs, contributing to continuous improvement and compliance across operations.
How you will contribute
- Define, document, and implement activities, processes, and standards to ensure fulfillment of quality and regulatory requirements
- Audit and monitor processes and outputs to ensure alignment with established quality standards and procedures
- Perform product integrity testing to verify compliance with quality specifications
- Identify, document, and report process deviations, non-conformances, and defects
- Independently manage assigned projects and quality-related processes with limited supervision
- Provide coaching, guidance, and review of work performed by junior or lower-level professionals
What you bring to Takeda
- A foundational understanding of quality assurance principles and regulatory expectations within a pharmaceutical or biotechnology environment
- Working knowledge of safety assurance requirements and a commitment to maintaining a strong quality and compliance culture
- Basic auditing experience, with the ability to apply standard audit techniques under guidance
- Problem-solving skills to identify quality issues and support corrective and preventive actions
- Experience investigating quality events using structured, basic root-cause analysis approaches
- Familiarity with change control processes and an understanding of fundamental quality system principles
- Ability to work within Quality Management Systems (QMS), applying core quality concepts effectively
- Strong attention to detail with a developing ability to identify critical quality elements
- Capability to prepare clear and accurate technical documentation, incorporating feedback for continuous improvement
- Exposure to biotechnology or pharmaceutical operations, with an understanding of basic biological and manufacturing processes
- Effective communication and collaboration skills, enabling productive interaction with cross-functional stakeholders
- A proactive mindset, accountability for assigned responsibilities, and a willingness to learn and grow within Takeda’s quality organization
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, IrelandWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeRecommended Jobs
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