CSV Compliance Analyst

For our esteemed partner, we are seeking a CSV Compliance Analyst (m/f/d) as part of a direct placement in a permanent role.

This position offers a unique opportunity to take on comprehensive responsibilities in CSV as a subject matter expert.

Here’s what our partner organization provides:

• A stable and permanent role directly with our partner organization
• Competitive salary, vacation pay, and 30 days of annual leave
• Annual employee bonus based on the achievement of company objectives
• Access to a company cafeteria, bike leasing options, and fitness programs
• Opportunities for professional development and training
• Participation in a company pension plan
• Availability of complimentary parking at the workplace

Key Responsibilities:

• Review and amend CSV (Computer System Validation) documentation
• Develop and assess Standard Operating Procedures (SOPs)
• Manage system inventory records
• Assist in both local and cross-site initiatives
• Enforce compliance with regulatory standards
• Define, execute, and monitor actions related to change and deviation management
• Conduct internal training sessions

Candidate Profile:

• Proven experience in CSV within cGxP environments and familiarity with automation technologies
• Understanding of regulatory frameworks (e.g., EU GMP Annex, 21 CFR Part 11, USP , GAMP, PIC/S)
• Proficient in MS Office, with advanced Excel skills preferred
• Excellent communication abilities coupled with a responsible and analytical approach to work
• Strong command of written and spoken German, along with good English proficiency