IT Compliance Specialist (m/f/d)

Where people make the difference

The working day at Midas Pharma is varied and challenging. This challenge motivates and inspires us. This is also reflected in the people who work here: our employees make the difference.

We know: In the team we achieve more. This is how knowledge transfer works, only so we create the synergies that make us so successful as a company. This is why teamwork is self-evident. For our employees, this means: here there are spaces to move and take responsibility. Commitment, expertise and creativity meet flat hierarchies, short decision-making and highly-competent colleagues. An inspiring environment that motivates you to go one step further. Working for our customers and developing their own skills.

Implementation and monitoring of regulatory requirements (including EU-GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, CSA) as well as maintenance of the associated IT policies and SOPs Responsibility for Computer System Validation (CSV/CSA), including validation documents, risk analyses and periodic reviews Qualification of IT infrastructure (servers, networks, cloud platforms) as well as evaluation of cloud services regarding compliance Assessment of Changes in GxP relevance and Ensuring Conform Change/Incident Processes Qualification and evaluation of IT service providers and cloud providers including support for Supplier Audits Preparation and monitoring of internal and external audits and authority inspections (e.g. FDA, EMA), incl. tracking of Findings and CAPAs Compliance/CSV Advice on IT and specialist areas as well as training on CSV, CSA and Data Integrity

Complete study of computer science, economic informatics or comparable qualifications Multiannual experience in the regulated pharmaceutical, biotech or life science environment Knowledge of GxP requirements, EU-GMP Annex 11, FDA 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 as well as a structured, independent way of working Communication strength and high consulting and service orientation Very good knowledge of German and English

A responsible key role at the interface of IT, quality and compliance Individual training and development opportunities Flexible working time models and modern working environment Various benefits such as JobRad, EGYM Wellpass, staff restaurant, regular events etc. We have flat hierarchies and small teams. This allows us clear and direct communication channels that lead to fast decision-making processes We are looking for you as a personality and want you to be authentic – we are promoting this through great freedoms for creativity and self-sufficiency