Regulatory Affairs Specialist

3 days ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time
Job Description

This role will be part of the Plant Engineering (PLE) department, responsible for executing technical projects, including facility projects, and overseeing the operation of all utility and facility systems, maintenance, and calibration across our facility.

The successful candidate will report to the Team Leader of the Support & Compliance (S&C) Team in Plant Engineering. The S&C Team handles all quality-related tasks such as deviations, technical system changes, CAPAs, and procedures, as well as our electronic maintenance systems.

The responsibilities include cooperating with colleagues within the department and stakeholders from other departments to ensure compliance is maintained at the appropriate level. You will handle quality documents such as deviations, change controls, CAPAs, and procedure updates, working alongside your team members.



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