Provide engineering expertise to the QA/QC, production and technical organizations to ensure the following: compliance to all cGMPs in issues that affect marketed products and/or their raw materials, APIs, excipients or components.
Responsible for QA oversight and auditing of Research and Development documentation related to radiopharmceutical clinical products ensuring compliance with Good Laboratory Practices (GLP) and production of clinical trial materials.
Maintain oversight of the User, Functional, and System Requirements to meet the IQ/OQ/PQ testing objectives while managing a Traceability Metrix to verify all testing is conducted and properly documented.
Ensure proper validation protocols and reports are developed and followed to ensure compliance with LMI validation guidelines, pharmaceutical industry requirements and regulations (e.g., FDA, EMA, PIC/s).
Maintains current knowledge of, and ensures all work team activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures.
Works closely with cross functional teams in a collegial and proactive manner on a broad range of projects related to the growth of the business; e.g., M&A, Strategic Planning, and Operational Excellence.