Risk & Compliance Analyst
Bratislava, BratislavaAt Takeda, we are guided by our purpose of creating better health for people and a brighter future for the world. Every corporate function plays a role in making sure we — as a Takeda team — can discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
People join Takeda because they share in our purpose. And they stay because we’re committed to an inclusive, safe and empowering work environment that offers exceptional experiences and opportunities for everyone to pursue their own ambitions.
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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.
Key Responsibilities
- Support in the Validation Life Cycle of Computerized Systems with special attention to laboratory and R&D systems: Drafting of Validation Plans; Drafting and Review of Specification documentation.
- Specification of User Requirements.
- Risk Analysis.
- Drafting of DQ, IQ, OQ and PQ testing protocols.
- Execution of validation tests and the phase reports.
- Provider support during systems implementation.
- Drafting and Review of Standard Operating Procedures (SOP).
- Acting of IT/QA Compliance: Evaluation of the State of compliance of the Computerized Systems with respect to the requirements of Data Integrity. Proposal for remedial actions based on the level of risk associated with the GAPs found.
- Support and execution of Data Integrity Compliance remediation actions on Laboratory and Production Systems.
- Review of generated validation documentation.
- Preparation/updating of Policies, SOPs, Standards and Validation Templates regarding standards and Corporate Policies.
- Review of Validation documentation regarding compliance with SOPs and approved validation standards.
Qualifications
- Min 2 years of experience in a similar role
- Bachelor's degree in a relevant field (e.g., Life Sciences, Computer Science).
- Preferred, experience in computer system validation.
- Preferred, knowledge of regulatory requirements and guidelines applicable to the pharmaceutical and biotechnology industry.
- Strong analytical and problem-solving skills.
- Excellent communication and collaboration skills.
- Attention to detail and a commitment to data integrity and quality.
Locations
SVK - Bratislava – SvatoplukovaWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeSuccess profile
What makes a successful team member within Corporate at Takeda?
- Collaborative
- Strategic
- Insightful
- Results driven
- Goal-oriented
- Achiever
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Impact across generations Partnership brings together world-leading plasma companies to focus on developing and delivering a hyperimmune immunoglobulin in the global fight against COVID-19.
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Takeda Scoops Global Top Employers® Award Takeda Pharmaceutical Company Limited today announced it has become part of a select group of only 15 to receive Top Global Employer® status for 2024.
Working at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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