Overview
Sr. Principal Associate-GQAAC Jobs in Indianapolis, IN at Lilly
Position Overview:
We are seeking a detail-oriented Compliance Engineer to support the Execution Systems (Automation) group within the Life Sciences industry. This role will focus on ensuring system compliance with industry regulations by managing CAPAs, leading investigations, and maintaining Standard Operating Procedures (SOPs). The ideal candidate will collaborate closely with cross-functional teams to support automation systems, drive process improvements, and ensure audit readiness.
Key Responsibilities:
Manage and support Corrective and Preventive Actions (CAPAs), ensuring timely closure and proper documentation.
Lead root cause investigations for system-related deviations and non-conformances, ensuring alignment with GMP and FDA guidelines.
Develop, review, and update Standard Operating Procedures (SOPs) related to automation and execution systems.
Support change control processes, ensuring compliance with regulatory requirements.
Collaborate with the Automation Engineering and Quality teams to validate new and modified systems, including documentation of IQ, OQ, and PQ protocols.
Assist in internal and external audits, providing documentation and addressing findings.
Conduct risk assessments and ensure mitigation plans are implemented for system changes.
Maintain compliance documentation, ensuring readiness for regulatory inspections.
Stay current with industry standards, emerging technologies, and evolving compliance requirements.
Keep track and monitor Department Quality Records Due dates and tasks. Weekly presentation of the Quality Records to Department Lead.
Qualifications:
Bachelor’s degree in Engineering, Life Sciences, or a related field.
3+ years of experience in compliance, quality, or validation within the Life Sciences industry, with a focus on automation systems.
Strong understanding of GMP, FDA regulations, and ISO standards.
Experience with CAPA management, root cause investigations, and change controls.
Proficiency in developing and maintaining SOPs and compliance documentation.
Excellent organizational, problem-solving, and communication skills.
Ability to collaborate with cross-functional teams and manage multiple priorities.
Tipo de puesto: Tiempo completo
Lugar de trabajo: Empleo presencial
Title: Sr. Principal Associate-GQAAC
Company: Lilly
Location: Indianapolis, IN
