analytical compliance record specialist (m/f/d).

Tasks & Responsibilities:
 

• Work in a modern quality control organization in compliance with cGMP regulations.
• Management of Compliance Records for the department, mainly Deviations, Changes and CAPAs
• Stakeholder management for the compliance record (including QA, Scientists, Senior Management)
• Facilitation and Documentation of Root Cause Analyses
• Active Participation in Quality Review Boards and other strategic and quality relevant governing bodies as needed
• Inspection Support, including preparation and presentation of records to internal and external auditors / health authority inspectors
• Critical evaluation of own work results
• Key role in ensuring an appropriate GMP standard in the department
• Scientific and regulatory documentation of the work done

• Advanced Degree (Bachelor’s, Master’s, or higher) in a relevant Natural Science field (e.g., Chemistry, Pharmacy, Biology)
• Alternative Qualification: Candidates with a Laboratory Technician background will be considered if they possess over 10 years of high-level GMP experience
• Between 3 to 5 years of professional experience within a regulated pharmaceutical or biotech environment
• Proven, hands-on experience working under cGMP (current Good Manufacturing Practice) regulations is mandatory
• QMS Software: Proficiency in Veeva Vault or a comparable Quality Management System (e.g., TrackWise)
• Core Competencies: Demonstrated ability in managing compliance records, specifically Deviations, Change Control, and CAPAs
• Business fluency is mandatory (written and spoken) for documentation and stakeholder management
• Proficiency in German is considered a strong asset and highly beneficial for internal communication

Nice to Haves:
 

• Prior experience as a Deviation/CAPA Owner or previous experience in a Quality Assurance (QA) role

Sounds interesting? Apply now - we are looking forward to receiving your application!