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Senior Quality Assurance Engineer Lead

Novartis

Novartis

Quality Assurance
United States
Posted on Wednesday, November 22, 2023

About the Role

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Engineering professionals to help us reach our ambitious goals.

The Sr. Quality Assurance Engineer Lead is responsible for the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at the Indianapolis radioligand manufacturing site.

Responsibilities include but not limited to:

• Provides strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters).

• Provides oversight of the Computerized System Validation Lifecycle efforts to ensure compliance with 21 CFR Part 11, EudraLex Annex 11, and applicable FDA/EMA Guidance's on electronic data integrity Contributes to design of facility, utilities and process equipment from a Quality and Compliance perspective.

• Provide Quality oversight, review, and approve Validation Documentation including but not limited to: Validation Master Plan, User Requirements, Functional Requirements, Installation Qualification, Operational Qualification, Performance Qualification, Trace Matrix, Validation Summary Reports, and Change Controls.

• Supports the Qualification and Validation activities in relation to QC and manufacturing equipment, utility and facility design.

• Review and approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration)

• Ensure that vendor assessments, audits and quality agreements (if required) of suppliers of GxP computer software are in place