(Senior) Consultant for Computerized System Validation (CSV) Pharma/Medical (60-100%, all genders)
The MRL cluster excels in providing comprehensive solutions for the manufacturing, retail, logistic, and life sciences industries. Covering a wide range of services, including strategic consulting, process optimization, organizational development, and technical implementation. Positioned as thought leaders, we aim to seize exciting opportunities with our clients by showcasing our expertise and innovative approach.
With a focus on driving growth and enhancing operational efficiency, the MRL cluster plays a vital role in helping organizations navigate complex challenges and achieve their goals.
Together with the team, you support our customers in the pharmaceutical/medical sector in the creation of validation plans and project reports.
You also take care of the execution and documentation of risk analyses and FMEAs. In addition, you create CSV/qualification documents according to GxP as well as specified customer processes. This also includes filing in the respective document management system.
You clarify requirements with other departments and clients and work together with project managers, the quality department and other stakeholders.
You will also be responsible for processing validation tasks in accordance with specified processes and providing support in projects when it comes to validation and qualification issues. In addition, you will support other projects related to regulatory compliance, risk management, audits and governance.
You would like to join our team with your experience in validation and qualification of computer systems in a highly regulated environment.
You are familiar with the following guidelines and regulations: CSV, GxP or EU GMP Annex 11, CFR 21 Part 11, GAMP5.
You have further education in compliance, risk management or quality management or are interested in further education.
You are able to communicate complex solutions to our customers in German and English.
We look forward to receiving your direct application via our website. To enable us to consider your application, we need your complete application documents (CV, diplomas and references) in PDF format. If you would like to give us more information about yourself, we would be delighted to receive a letter of motivation from you.
We do not consider applications by e-mail or from recruitment agencies.
For further information, please contact Tamara (Write an email).
Our top priority is that you fit in with us and we with you, regardless of origin, nationality, sexual orientation, religion, gender identity, age, disability or other aspects of diversity.
