• Deviations: Conducted investigation, root cause analysis, trend analysis and determination of appropriate corrective and preventative actions with consideration of internal and external stakeholders' requirements• Consolidated and reviewed documentation for lot disposition• Reviewed batch records• Analyzed data and drafted Annual Product Review reports and Quality Management Review presentations• Administrator of site’s labeling system: Provided training. Approved and managed manufacturing and product status/export labels• Created and reviewed QA SOPs and forms to ensure cohesiveness• Managed Change Requests and provided Quality Assessments• Performed internal audits• Created and executed Hoshin projects for on-time delivery/ lot release • Performed finished product label printing and labelling. Provided training on printing system and labelling• Performed Changeover release of production equipment and systems

- Revised local site procedures to ensure alignment with global sites and regulatory requirements- Assisted in drafting response reports for regulatory and external audits- Prepared documents and logistics, and provided support for site audits- Assisted in creating presentation slide deck for GMP Refresher Training- Created audit observation pareto charts for Quality Management Review Report- Conducted GMP walkdown of QC labs, warehouse and manufacturing to ensure on the floor GMP compliance

• Oversaw the systematic consolidation and archival of all batch records and logbooks used in each production run • Coordinated product lot releases with warehouse: - Prepared QA document package for shipment, controlled printing and tagging of labels on product• Drafted and revised cGMP documents• Reviewed batch records and logbooks and raised deviation reports when necessary• Managed review and approval workflows of cGMP documents on Documentum Document Management System• Safety, Health and Environment representative of QA department - Performed monthly safety inspection of work areas to identify and record hazards - Followed up with personnel to ensure hazard is removed - Wrote monthly site safety inspection reports