Software Quality Assurance

Lake County, Illinois
May 09, 2022
Required Education
Bachelors Degree
Position Type

Software Quality Assurance ensures computer system software meets requirements and is validated throughout the system's and the drug development's life cycles. The functional group will ensure high quality products and data compliant with GxP regulations, internal policy/procedures as well as FDA (GCP/GLP/GMP/21CFR Part 11), SOX, HIPPA, and International (ICH, Annex 11). We have a challenging opportunity for an IT Compliance Consultant based in North Chicago, IL., reporting to the Senior Software Quality Assurance Manager.

Key responsibilities include:

•Author, review/audit, and approve project documentation associated with the SLC to support applicable federal and regulatory requirements

•Review/approve various qualification/validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate

•Ensure recommended changes/improvements to support the Enterprise Systems are compliant to the internal and external policies, processes, and procedures

•Establish quality system requirements for the Information Enterprise Systems

•Provides project quality leadership for validation or SLC activities

•Create and apply risk-based approach strategies effectively and efficiently without compromising compliance

•Approve key project deliverables

•Serves as expert resource with regards to the Enterprise Systems and compliance issues

•Generate or review and provide feedback on various documents related to qualification/validation eg calibration, SOPs, VMPs etc

•Lead process improvement projects