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Compliance & Audit II
Ref No.: 18-08056
Location: Lake Forest, Illinois
Job Description: Candidate is required to have a basic understanding of manufacturing / pharmaceutical sciences / the pharmaceutical industry with an understanding of commercial manufacturing of pharmaceutical products with technical writing skills. Competent working knowledge of computer based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum). Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to support others in system use. Additionally, has sound understanding of Module 3 technical dossier and provide operational global CMC regulatory support and documentation for eCTD baseline project. Supports the assembly of CMC information for submission to global regulatory agencies and supports CMC strategies with supervision. Maintain CMC systems and perform data entry.
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