Quality Engineer - Katalyst Healthcares & Life Sciences
North Chicago, IL 60064
About the Job
Responsibilities:
- Provide interpretation, guidance, and training for clients regarding qualification and validation requirements in GLP-, GCP- and GMP-regulated areas of an R&D organization.
- Review / approve various qualification / validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate with minimal supervision.
- Compilation, review and approval of quality documents (Policies, Processes, Procedures, templates, formats etc.).
- Support CAPA activities related to validation and qualification.
- Provide guidance, direction, and support to peers.
- Technical science and/or engineering education.
- Experience in life sciences industry, preferably in pharmaceutical GMP and/or GDP regulated environment.
- Experience with pharmaceutical qualification/validation processes, preferably with shipping, equipment and/or facility qualification/validation.
- Experience writing technical reports and quality system procedures.
- Experience writing, coordinating and executing qualification/validation activities (including validation plans, protocols, summary reports).
- 4-year college degree; preferably a BS in Chemistry, Biology, Engineering Pharmacy, or Microbiology.
- Minimum of 4-7 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification / validation, documentation or compliance.
- Sound knowledge of the current regulatory requirements (21 CFR Part 11, EU GMP Annex 11 / 15, ICH, PIC/S) and Best Practices (GAMP5, etc.).
- Conducting or providing QA oversight of Equipment, Facility, Utility, Instrument qualification and Cleaning, Automated Process Controller, Qualification and Validation.
- Excellent communication capabilities and teamwork capacities.
- Proven ability to work in a global environment and on virtual teams.
Source : Katalyst Healthcares & Life Sciences
