Compliance Engineer - Katalyst Healthcares & Life Sciences
Round Lake, IL 60073
About the Job
Responsibilities:
- Support internal audit process ensuring compliance with all applicable regulations and standards.
- Knowledge of cGMP and global regulatory guidelines such as EMA, FDA, and other health agencies.
- Knowledge of Six Sigma methodology and LEAN principles.
- Effective communicator at all levels; excellent written, oral, and interpersonal communication and presentation skills.
- Experience with pharmaceutical and/or device quality and compliance management systems, desired.
- Hands-on experience in drug product aseptic manufacturing operations is desired, but not required.
- At least 5 years of directly related experience within the pharmaceutical industry or medical device experience.
- BS in Science or Engineering. Advanced degree a plus.
- Project management experience preferred.
- Previous experience with due diligence, auditing, compliance management or regulatory experience is a plus.
Source : Katalyst Healthcares & Life Sciences
