Precise Solutions Software Quality Assurance Engineer in Waukegan, Illinois
Precise Solutions is an Illinois BEP/FBE (female owned business enterprise) certified consulting company founded in 2000. Our mission is to provide companies with specialized resources that can drive their system portfolio projects using program management processes, change management and blended learning solutions. Please visit our website at www.precise-solutions.com
At Precise Solutions, we are looking for top talent consultants to bring on as employees of our organization and service our clients in the pharmaceutical and healthcare industries primarily located in the Northern Chicago Suburbs. We are much more than a consulting firm! Precise Solutions provides competitive compensation packages with great salaries, benefits, health insurance, paid time off and pension.
We currently have an immediate need for the following:
SOFTWARE QUALITY ASSURANCE ENGINEER- BIG PHARMA
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 a Software Quality Engineer 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 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
Participate on process improvement projects
- 4 year college degree (preferably BS) in Computer Science, Engineering, Chemistry, Pharmacy, Biology, or Microbiology.
- Minimum of 4 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification/validation, documentation or compliance.
Builds strong relationships with peers and cross functionally and with partners outside of the team.
Learns fast, grasps the ?essence? and can change course quickly where indicated. Raises the bar and is never satisfied with the status quo.
Creates a learning environment, open to suggestions and experimentation for improvement.
Embraces the ideas of others, nurtures innovation and manages innovation to reality.