Responsible for quality oversight of incoming raw materials, manufacturing floor operations, facility/utility qualification and routine support, and QC laboratory investigations. This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing. This position will be responsible for review and approval of procedures and methods supporting all aspects of GMP operations, including support of client and regulatory audits.
Emphasis on this position is direct manufacturing support in the production environment.
- Performs compliance review on the following records: batch record (includes on-the-floor review of records); release data
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