Global biopharmaceutical company
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.
- 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 International Commercial Systems are compliant to the internal and external policies, processes and procedures
- Establish quality system requirements for the International Commercial 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 International Commercial Systems and compliance issues
- Generate or review and provide feedback on various documents related to qualification/validation e.g. calibration, SOPs, VMPs etc.
- Participate on process improvement projects
- 4 year college degree (preferably BS) in Computer Science, Engineering, Chemistry, Pharmacy, Biology, or Microbiology.
- Advanced English & Japanese(Writing, Reading , Speaking)
- Minimum of 4 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification/validation, documentation or compliance.
Mon to Fri
[Work hours and any overtime hours]
8:45 - 17:30
overtime hours: 10-20 hours/month
[Length of contract]
ASAP~ Long term
[Hourly Salary and Transportation]
4200 yen ~
(Experiences and skills will be considered)
※Please click "apply" if you are interested in the job.
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Further details about the company and position will be notified at a later date.