- Knowledgeable and Compliant with FDA , MSHA, and 21 CFR part 210 and 211 regulations.
- Developed and implemented Annual Product Review and Management Review.
- Demonstrated excellence in communication skills with various levels of state and federal regulators.
- Manage Active Pharmaceutical Ingredient laboratory.
- Evaluate and approve raw material suppliers.
- Provide accurate documentation of statistical reports.
| - Review and approve Out of Specification (OOS) investigations, Deviations, CAPAs, and Change Controls per cGMP procedures.
- Manage client correspondence from project initiation to site audits.
- Proficient in Microsoft office.
- Coordinate and perform raw and finished good inventory management.
- Trained in Salesforce and ERP.
- Recommend and implement corrective actions.
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