Quality Assurance Manager (all genders) Computer System Validation (CSV)

Your mission

• Planning, coordinating, and implementing the validation of computer-based systems in accordance with applicable regulations
• Ensuring compliance with legal requirements during all phases of the validation of computer-based systems
• Managing all documents generated in the course of validation projects
• Conducting risk management in the context of computer validation (CSV)
• Ensuring data and system security
• Serving as the primary point of contact for all questions related to validation processes
• Planning, overseeing, and monitoring validation, and qualification activities
• Managing computer-based systems throughout their lifecycle, including conducting periodic reviews
• Coordinating and addressing deviations, changes, and CAPAs
• Preparing and reviewing GMP-related documentation

Your profile

• Degree in computer science or natural sciences and several years of professional experience in quality management in the pharmaceutical industry
• Sound knowledge of the validation of computerised systems in the pharmaceutical industry
• You are familiar with the current GMP requirements and guidelines for the validation of computerised systems (GAMP5)
• High organisational skills, result-oriented way of working and quick adaptability
• Good communication skills, enjoy interdisciplinary work
• Very good knowledge of German and English

Our Offer

• A job in an established and renowned family business that offers you the security of over 35 years in business as well as a personal and appreciative working atmosphere
• Flexible working hours and 30 days' vacation
• Comprehensive training opportunities with a fixed annual training budget
• A modern working environment
• Various benefits such as JobRad, EGYM Wellpass, employee restaurant, regular events and much more.
• We have flat hierarchies and small teams - this enables us to have clear and direct communication channels that lead to fast decision-making processes
• We are looking for you as a personality and want you to make an authentic contribution - we encourage this in turn by giving you plenty of scope for creativity and independence