Principal Associate Quality Assurance - FUME

Responsibilities

• 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.
• Able 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.
• 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.

Qualifications

• 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.