PRD QA Engineer

We’re looking for people who are determined to make life better for people around the world.

Organization Overview :

Product Research and Development (PRD) Quality Assurance (QA) is responsible for providing quality oversight of all materials used in clinical trials. The PRD QA Engineer is responsible for oversight of Facilities, Utilities, Maintenance, and Equipment (FUME) and computer systems (CSQ) within PRD and assures compliance with quality systems and current Good Manufacturing Practices (cGMP). This oversight includes supporting biologic drug substance, parenteral drug product, and distribution facilities.

Responsibilities :

The PRD QA Engineer provides technical guidance and leadership in a variety of interactions with business and operations personnel. More specific examples include :

• Provide consultation and interpretation of local procedures, corporate standards, and regulatory expectations.
• Review and approve applicable procedures to ensure compliance with corporate standards and regulatory requirements.
• Assess potential gaps between local procedures and corporate standards and facilitate remediation efforts.
• Influence and oversee Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV) of GMP assets including review and approval of associated deliverables (protocols, drawings, test documents, etc.).
• Influence and oversee Maintenance / Calibration programs within PRD, including benchmarking with other Lilly sites.
• Evaluate potential product quality impact for any GMP-related incident (deviation or change control), perform initial assessment, and support the investigations to ensure proper root cause analysis (RCA) and establishment of effective corrective and preventive actions (CAPA).
• Escalate and / or initiate notification to management for departures of critical nature and assure issues are addressed appropriately.
• Ensure PRD is audit ready at all times and participate in internal / external inspections.

Basic Requirements :

Additional Skills / Preferences :

Additional Information :

Lilly is an EEO / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include : Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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