GMP Specialist – All Gender

ALTEN

GMP Specialist ensuring compliance in pharmaceutical processes at ALTEN, a leading engineering service provider. Collaborate with cross-functional teams in quality assurance and process validation.

Posted 5/23/2026full-timeRemote • 🇩🇪 GermanyMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

You will ensure GMP compliance in development, production and/or quality processes
You will create, review and release SOPs, batch records, deviation reports, as well as CAPA and change-control documents
You will support audits, inspections and qualifications
You will perform process validations (CQV, CSV) and conduct trainings in a GxP environment
You will collaborate in interdisciplinary projects focused on process optimization, data integrity and digitization
You will work closely with Production, QC, Regulatory Affairs and Engineering

Requirements

What you’ll need

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 of quality assurance, validation, documentation or production
Team-oriented, goal-driven and highly committed
Fluent in German and English, both written and spoken

Benefits

Comp & perks

Talent Management – we develop your career
Work–life balance – flexible working hours and the option to work remotely
Fit and relaxed – with EGYM Wellpass
Enjoy biking – benefit from company bike leasing
Green Mobility – discounted travel options
We also offer a permanent contract, corporate benefits and team events

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GMP complianceSOPsbatch recordsdeviation reportsCAPAchange-control documentsprocess validationsCQVCSVquality assurance

Soft Skills

team-orientedgoal-drivenhighly committed