Provide quality oversight for the verification and qualification of the commissioning and qualification documentation, including review of URS, test cases, protocols, discrepancies resolution, traceability matrix, summary reports, periodic reviews, etc.
Proven experience with C&Q / Verification and Validation oversight including automation and computer systems validation.
Provide technical and quality review and approval of documents to ensure compliance with Lilly Global Quality Standards and local quality procedures.
Ability to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents).
Support the QA Compliance team and site in the execution of the site readiness plan with focus on supporting start-up and ongoing quality oversight of site FUME systems including working as part of the site Utilities Process Team and Business Quality Assurance for local computer systems.
Work with the Site Compliance Manager to support the development of the vision and strategy for the overall site quality operation with focus on the FUME areas.
Support inspection readiness activities and provide support for internal / external regulatory inspections, as it relates to facility, utilities, equipment, and maintenance.
Contribute to and review asset qualification maintenance system strategies and equipment/computer system periodic reviews, as appropriate.
Support inspection readiness activities and provide support for internal / external regulatory inspections, as it relates to facility, utilities, equipment, and maintenance.
Participate in continuous improvement projects to help improve productivity within the local process team or quality organization.
Foster a strong quality culture, maintaining open communications.
Responsible for adhering to safety rules and maintaining a safe work environment for both you and others by supporting HSE corporate and site goals.
Requirements
Bachelor's degree in engineering, or a science-related field or equivalent experience.
Minimum of 5 years working in the pharmaceutical GMP industry within QA roles.
Previous Pharmaceutical FUME experience.
Additional Skills and Preferences:
Ability to organize and prioritize multiple tasks.
Proven experience in QA, TS/MS QC or Engineering.
Proven facility or area start up experience.
Proven experience with GMP utilities including WFI, Clean Steam, Process Compressed Air.
Proven experience handling deviations, performing root cause analysis, and managing CAPAs and Change Controls.
Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills.
Effective problem-solving and analytical skills to resolve operational issues.
Demonstrated knowledge and use of US, EU, Japan and other regulations in facilities, utilities, and equipment.
Demonstrated strong written and verbal communications skills.
Strong attention to detail.
Proficiency with computer system applications (e.g. KNEAT, Veeva, TrackWise, SAP, GMARS, etc.).
Understanding of statistical tools and analysis.
Additional Information:
Ability to work 8 hour days - Monday through Friday
Use of safety gear and adherence to site-specific safety requirements as needed.
Work Authorization:
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Benefits
Health insuranceVision insurance
Additional Information
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Eli Lilly · Houston TX