Manage the process validation program Test method validation Gage R&RIQ/OQ/PQ/PPQ for CNC machining, finishing, cleaningSupplier validation Creation of validation plansManage the Process Risk Management ProgramDevelop and Deliver training on validation and risk management topics.

• Manage the Quality Risk Management (QRM) Program • Facilitate Risk Assessments, advise on risk assessment methodology, maintain adherence to internal risk management guidelines, ensure periodic reviews were completed on time• Provide Quality Validation support to Facilities, Utilities, Tank Management, Freeze and Thaw Processes, Cleaning, Filling, and Formulation to ensure compliance with internal and regulatory standards.• Advise on validation approach and testing for DQ/IQ/OQ/PQ • Support internal and external audits by presenting QRM topics, fulfilling and managing audit requests, and working as an internal auditor• Trained Site Self Inspector - Conducted internal audits• Managed the Pharmaceutical Quality System (PQS) documents

CIP/SIP Cycle Development,DQ/IQ/OQ , SOP Development, Protocol and Summary Report Writing, Created Bill of Materials

HPLC, ICPMS

HPLC, small scale purification