Quality Engineer - Katalyst Healthcares & Life Sciences
Round Lake, IL 60073
About the Job
Responsibilities:
Requirements:
- JOB SUMMARY: Schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System.
- Conducts internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines and compendia as requirements.
- Supports management during external inspections and participates in the preparation, coordination, and management of external inspections as required.
Requirements:
- 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