The QA Engineer supports the site with focus on oversight, guidance and support in the area of Facilities, Utilities, Maintenance, and Equipment. The QA Engineer position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies.
- Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.
- Participate in continuous improvement projects to help improve productivity within the local process team or quality organization.
- 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).
- Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
- Resolve or escalate any compliance issues to the project, site, and Quality Management.
- Provide quality oversight for the verification and qualification of facility, utility, and maintenance systems including review of test cases, test execution, discrepancy resolution, etc.
- Participate in self-led inspections and provide support during internal/external regulatory inspections.
- 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 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.
- Lead project initiatives needed in support of the project and Quality function.
- Act as a FUME SME, working with Global Facilities Delivery, Lilly project staff, Global CSQA, and selected service provider firms to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Lilly Global Quality System requirements into the design:
- Consult with Network and Global quality groups including GQS and Global Quality as required to ensure a consistent and compliant approach is executed during the project and startup phase.
- Provide technical and quality review and approval of project FUME system documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures.
- Interact with the other global, project and functional areas to coordinate design and start up activities to support the overall project and site schedule.
- Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring of new Quality and other project staff.
Qualification & Experience:
- Experience with FUME systems qualification including regulations governing them.
- Bachelors degree in engineering, computer science, or another science related field preferred.
- Demonstrated strong technical writing skills.
- At least 7 years working in the pharmaceutical QA roles.
- Previous Pharmaceutical FUME experience.
- Demonstrated strong oral and written communication and interpersonal interaction skills
Company: Eli Lilly
Vacancy Type: Full Time
Job Location: Cincinnati, OH, US
Application Deadline: N/A