Automation & Quality Systems Specialist (GxP, 21 CFR 11)

360Pharma

Netherlands

On-site

EUR 65,000 - 90,000

Full time

3 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

360Pharma is seeking an experienced Automation Specialist with a strong interest in analytical methods and computerized systems to support our QC laboratories. As the Subject Matter Expert for automation, you will support data integrity, the implementation and maintenance of computerized systems, and laboratory robotics.

You will help ensure GMP compliance and contribute to LEAN improvements across the team and its processes.

Qualifications

Bachelor’s degree (HBO) in Life Sciences, Computer Science, or equivalent experience.
Basic understanding of GMP regulations, FDA/EMA guidelines, and quality-control best practices.
At least two years in the pharmaceutical industry with GMP and automation responsibilities.
Hands-on software development experience; laboratory exposure is a plus.
Experience with computerized system validation in a GxP environment.

Responsibilities

Lead the technical implementation of new laboratory systems with cross-functional teams.
Create and maintain installation, maintenance, and procedural documentation.
Provide timely support and troubleshoot issues involving computerized systems.
Ensure equipment implementations comply with 21 CFR Part 11 requirements.
Contribute to laboratory system initiatives and projects across the global organization.