James Christian

Quality Assurance Associate @RK Pharma Inc

Pearl River, NY, US

Review of Master Batch Records, Equipment Cleaning Record, Process Flow Diagram, and SOPs.• Preparation and Review of Validation Master plan, Process Validation, cleaning Validation and hold time Protocols and reports and all Quality related documents and Review of calibration and preventive maintenance.• Review of Process Development Report, Equipment Qualification documents and APR.• Review of Technology transfer documents and coordinating technology transfer activity.• Actively participating in assisting internal audits, regulatory audits and facilitating Head Quality during audits.• Review of warehouse related documents and conducting vendor/Contract laboratories audits.• Review of Change Controls, Deviations, OOS, CAPA and other QMS documents and maintaining cGMP compliance.• Provides oversight of manufacturing unit operations (e.g. compounding, filling, packaging and inspection)• Ensure quality operations support for manufacturing and Responsible for all works assigned by the Quality Manager.• Review of critical equipment systems, & utility issues and investigations & establishes metrics to track operations.