Risk & Compliance Analyst

Job Description

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Job Description

Risk & Compliance Analyst

The Future Begins Here

At Takeda, we are creating a future-ready organization that uses data and digital to meet the needs of patients, our people, and the planet.

We need your help to make this happen. Join our new Innovation Capability Center (ICC) in Bratislava, Slovakia.

In this role at our state-of-the-art center, you will have the opportunity to grow your skills and create solutions that will benefit patients around the world. Become the heart of our internal innovation engine.

At Takeda we unite in diversity!

Takeda is committed to creating an inclusive workplace, where individuals are recognized for the diverse backgrounds and abilities they bring to our company. We are continually improving workplace experience and accessibility for everyone, and welcome applications from all qualified candidates. Here, you will feel welcomed, respected, and valued as an important contributor to our Team.

The Opportunity

As a Risk & Compliance Analyst you will develop and execute a strategic CSV plan that aligns with the company's overall compliance and quality objectives. This includes defining validation strategies, risk assessment methodologies, and validation lifecycle models.

Responsibilities

• Oversee the development and review of comprehensive validation documentation, including Validation Plans, URS, FS, IQ/OQ/PQ protocols, validation reports, and traceability matrices.
• Conduct risk assessments for computer systems, identify potential vulnerabilities, and implement risk mitigation strategies.
• Establish and maintain a robust change control process to manage system changes and updates in compliance with validation requirements.
• Provide guidance on validation testing methodologies, including test design, execution, and documentation. Ensure that testing meets regulatory expectations.
• Work with other departments to ensure alignment for an agreed upon state of control for computer systems.
• Practice and stay current with ISPE GAMP best practices, FDA and EU GxP regulations, and applicable ISO standards.
• Manage a team of professionals to drive validation activities for computer systems.
• Work with other departments to ensure alignment for an agreed upon state of control for computer systems.

Qualifications

• Min 5+ years of experience in a similar role
• Exposure to ERP/AI, automation
• Bachelors or Master's degree in a relevant scientific or engineering discipline (e.g., Computer Science, Engineering, Chemistry, Pharmacy, or related fields).
• Extensive experience in computer system validation, particularly in laboratory, R&D and clinical trial environments.
• In-depth knowledge of relevant regulations, guidelines, and industry standards related to CSV, data integrity, and computerized systems (e.g., GAMP 5, 21 CFR Part 11).
• Strong analytical and problem-solving skills.
• Excellent communication and collaboration skills.
• Attention to detail and a commitment to data integrity and quality.

What Takeda Can Offer You

At Takeda, you may build your career, while contributing to better people’s lives. Expect trust driven culture built around Integrity, Fairness, Honesty and Perseverance. Joining ICC will give you access to high end technology, training and colleagues who will support your growth.

Salary

As a motivated employee, you should be compensated appropriately. The minimum salary for this position is € 2800 per month (full time), but your final remuneration package may be higher depending on your qualifications and experience.

Benefits

Here are a few benefits our employees are enjoying at Takeda. To get a full picture of what we are offering, follow this link.

• Cafeteria
• Medical - High standard medical care
• Bridge days
• Summer Hours
• Multisport Card

Your application and any and all conversations that occur with the recruiter, HR, and the hiring manager as part of that application will be treated in the strictest confidence.

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