(Sr.) CSV Manager (m/f/x) | Mainz Area | Pharma
Join a trusted and innovative pharmaceutical company as a key expert (m/f/x) in computer system validation. Your expertise will guide essential validation processes, and you’ll engage in exciting projects that make a real difference in advancing healthcare solutions.
These tasks are waiting for you:
* Planning, coordination, and execution of computer system validation in compliance with current regulations
* Ensuring regulatory compliance throughout all stages of computer system validation
* Conducting risk management within the scope of computer system validation (CSV)
* Managing all documentation generated during validation projects
* Preparing final validation reports and ensuring data and system security
* Planning, supervising, and monitoring validation, qualification, and calibration activities
* Coordinating and overseeing deviation management
* Preparing and reviewing GMP-related documentation
* Support in external audits
This completes your profile:
* Degree in Computer Sciences or comparable qualifications with relevant work experience
* 4+ years of professional experience in a CSV role, preferably in the pharmaceutical industry or medical device industry
* In-depth knowledge of regulatory requirements (GxP, CFR 21 Part 11/EU GMP Annex 11, GAMP5)
* Excellent communication skills and a methodical, quality-focused approach to work
* Fluency in both German and English
Benefits:
* Flexible working hours with 30 days of holiday
* Personal and professional development
* Health offers such as JobRad, Wellpass, and sports groups
* Collaborative and appreciative work environment, with flat hierarchies
Information about our client:
Our client is a well-established company in the pharmaceutical industry, offering end-to-end services across drug development, manufacturing, and supply chain management. Known for quality and innovation, the company provides a collaborative work environment focused on efficiency and quick decision-making, supported by a close-knit, professional culture.