Junior Specialist eQMS (m/f/d)

To strengthen our team responsible for the global Electronic Quality Management System (eQMS – Trackwise) and the Global Complaint Management System in a regulated (GxP) environment at our Bad Homburg site, we are seeking a new team member to start immediately. The role focuses on maintaining process documentation and SOPs, supporting requirements management and prioritization, assisting with quality assurance and compliance monitoring in line with regulatory standards (e.g., GxP, ISO), master data management (guidelines), especially managing harmonized and site-specific master data lists, user account administration, and creating and updating training content. 

Your assignments 

• Supporting system-related inquiries by analyzing and evaluating system errors and user requests for improvements and implementing solutions in collaboration with IT teams.

• Creating and revising work instructions.

• Designing and developing new training materials and conducting user training as a global trainer (including user manuals, training concepts, plans, materials, and presentations).

• Co-responsibility for the operation of the eQMS, ensuring compliance with all underlying regulatory requirements, including conducting periodic reviews in accordance with validation requirements.

• Participating in the evaluation and implementation of system requirements and changes within the change management process, in collaboration with relevant teams.

• Master data management (independent review and implementation within change controls).

• Independently contributing to specifications, risk assessments, and test planning and execution for system changes.

• Performing test activities (e.g., regression testing, error analysis, and documentation).

Your profile 

• A degree in a scientific discipline with at least 2 years of professional experience, ideally 2 years in the pharmaceutical industry, is preferred.

• Experience with computerized systems in regulated environments, particularly in computer system validation (e.g., GMP, 21 CFR Part 11, EU GMP Annex 11, GAMP 5).

• Experience in designing and delivering training on business processes and compliance requirements, including the creation of training documentation.

• Project management experience and proficiency in English communication, both written and spoken.

• Demonstrated ability to work effectively as part of a team.