(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.
Benötigen Sie weitere Hilfe? Greifen Sie zu an einen unserer Mitarbeiter.
Wir sind ein vertrauenswürdiger Partner für jeden Schritt von der Entdeckung bis zur Entwicklung. Egal, wo Sie sich auf Ihrer Reise befinden, wir sind hier, um Ihnen zu helfen, etwas zu bewirken. Wir sind ein vertrauenswürdiger Partner für jeden Schritt von der Entdeckung bis zur Entwicklung. Egal, wo Sie sich auf Ihrer Reise befinden, wir sind hier, um Ihnen zu helfen, etwas zu bewirken. an einen unserer Mitarbeiter.