Regulatory Compliance Expert

14 hours ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

Our purpose at AGC Biologics is to bring hope to life by enabling life-changing therapies for patients worldwide, creating a healthier and happier tomorrow.

Company Overview

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering exceptional service as we collaborate closely with our clients and partners. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.

With a global network spanning the U.S., Europe, and Asia, our cGMP-compliant facilities are located in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. Our diverse team consists of over 2,500 employees worldwide, committed to continuous innovation and fostering technical creativity to solve complex challenges.

Job Description

As a Compliance Engineer, you will play a vital role in ensuring compliance is maintained at an appropriate level. Your responsibilities include handling quality documents such as deviations, change controls, CAPAs, and procedure updates, working collaboratively with your team members.

Familiarizing yourself with related technical systems is essential to managing tasks independently, which pertain to components and issues across various utility, HVAC, and manufacturing systems.

You will contribute to the continuous improvement of our utilities, facilities, and systems, ensuring that these improvements are implemented within the quality system. In time, you will present documentation during audits and inspections. Your focus will be on both current and new facilities.

Required Skills and Qualifications

  • Relevant technical background as an engineer or equivalent technical experience in the pharmaceutical or process industry is required.
  • Knowledge of GMP is preferable, along with experience in operations, maintenance, or project participation, and most importantly, a passion for working with quality-related documentation.
  • Pragmatic and flexible approach, with a strong focus on achieving goals and personal drive to complete tasks effectively.
  • Structured approach to planning and executing tasks.
  • Good communication skills, including the ability to communicate clearly in both written and spoken English and Danish.

Benefits

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.

Location: Copenhagen Site



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