AbbVie

Principal Quality Engineer

Employer
AbbVie
Location
Lake County, Illinois
Posted
May 09, 2022
Ref
2202162
Required Education
Bachelors Degree
Position Type
Full time

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 Software Quality Assurance Manager – Software Life Cycle Management.

Responsibilities:

  • Lead a team of 5-6 contractors/employees as a team lead, handle invoicing, reviews
  • 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 Information Research are compliant to the internal and external policies, processes and procedures
  • Establish quality system requirements for the Information Research.
  • 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 Information Research and compliance issues
  • Generate or review and provide feedback on various documents related to qualification/validation eg calibration, SOPs, VMPs etc
  • Participate and take lead on process improvement projects
  • Provide guidance and supervision to contracting staff