- 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, qualification, and calibration activities
- Managing computer-based systems throughout their lifecycle, including conducting periodic reviews
- Coordinating and addressing deviations and changes
- Preparing and reviewing GMP-related documentation
Quality Assurance Manager (all genders) Computer System Validation (CSV)
Ingelheim
Full-time
Permanent employee
Your mission
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
About us
Where people make the difference
Everyday work at Midas Pharma is diverse and challenging. This is what motivates and inspires us. That is also reflected in the people who work here: Our employees make the difference.
We know: We accomplish more as a team. This is the only way to transfer knowledge and create the synergies that make us so successful as a company. That's why teamwork is a key factor for us. For our employees, this means that there is scope to make a difference and take on responsibility. Commitment, expertise and creativity meet flat hierarchies, short decision-making processes and highly competent team members. An inspiring environment that motivates you to go the extra mile. In the work for our customers and in the development of your own skills.
Everyday work at Midas Pharma is diverse and challenging. This is what motivates and inspires us. That is also reflected in the people who work here: Our employees make the difference.
We know: We accomplish more as a team. This is the only way to transfer knowledge and create the synergies that make us so successful as a company. That's why teamwork is a key factor for us. For our employees, this means that there is scope to make a difference and take on responsibility. Commitment, expertise and creativity meet flat hierarchies, short decision-making processes and highly competent team members. An inspiring environment that motivates you to go the extra mile. In the work for our customers and in the development of your own skills.