
GMP Specialist – All Genders
ALTEN
full-time
Posted on:
Location Type: Remote
Location: Germany
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About the role
- Ensure GMP compliance in development, production and/or quality processes
- Create, review and approve SOPs, batch records, deviation reports, as well as CAPA and change‑control documents
- Support audits, inspections and qualifications
- Conduct process validations (CQV, CSV) and deliver trainings in the GxP environment
- Participate in interdisciplinary projects for process optimization, data integrity and digitalization
- Collaborate closely with Production, QC, Regulatory Affairs and Engineering
Requirements
- Degree in Pharmacy or a comparable scientific discipline
- At least three years of professional experience in a regulated environment (GxP, ISO 13485, MDR, etc.)
- Knowledge in quality assurance, validation, documentation or production
- Team‑oriented, goal‑driven and highly committed
- Business‑fluent in German and English, both written and spoken
Benefits
- Talent management – we develop your career
- Work–life balance – flexible working hours and the option to work remotely
- Health & wellness – access to EGYM Wellpass
- Enjoy biking – company bike leasing available
- Green mobility – discounted mobility options with us
- Permanent employment contract
- Corporate benefits
- Team events
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMP complianceSOPsbatch recordsdeviation reportsCAPAchange-control documentsprocess validationsCQVCSVquality assurance
Soft Skills
team-orientedgoal-drivenhighly committed