Risk & Compliance Analyst
Date de publication :
16 octobre 2024Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Bratislava
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
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 – Svatoplukova
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time