- Implement and monitor regulatory requirements (e.g., EU-GMP Annex 11, 21 CFR Part 11, GAMP 5, CSA) and maintain related IT policies and SOPs
- Take ownership of Computer System Validation (CSV/CSA), including validation documentation, risk analyses, and periodic reviews
- Qualify IT infrastructure (servers, networks, cloud platforms) and assess cloud services for compliance
- Evaluate changes for GxP relevance and ensure compliant change and incident management processes
- Qualify and assess IT service providers and cloud providers, including support for supplier audits
- Prepare for and support internal and external audits and regulatory inspections (e.g., FDA, EMA), including tracking findings and CAPAs
- Advise IT and business departments and conduct training on CSV, CSA, and data integrity
IT Compliance Specialist (m/w/d)
Ingelheim
Full-time
Permanent employee
Your mission
Your profile
- Degree in computer science, business informatics, or a comparable qualification
- Several years of experience in a regulated pharmaceutical, biotech, or life sciences environment
- Solid knowledge of GxP requirements, EU-GMP Annex 11, 21 CFR Part 11, GAMP 5, CSV/CSA, and data integrity (ALCOA+)
- Experience with IT infrastructure, cloud technologies, and IT service management
- Analytical, risk-based thinking and a structured, independent way of working
- Strong communication skills and a high level of advisory and service orientation
- Very good German and English skills
Our Offer
- A responsible key role at the intersection of IT, quality, and compliance
- Individual training and development opportunities
- Flexible working hours and a modern working environment
- Various benefits such as JobRad, EGYM Wellpass, employee restaurant, regular events, and more
- We have flat hierarchies and small teams, enabling clear and direct communication that leads to fast decision-making
- We're looking for you as a person and want you to bring your authentic self to work – something we support through plenty of room 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.