An accomplished Regulatory and Clinical professional within the pharmaceutical industry, possessing extensive expertise in document publishing. Experience in implementing and maintaining quality management systems in FDA-regulated environments. Expertise in conducting internal audits, managing corrective and preventive actions (CAPAs), and ensuring adherence to cGMP guidelines. Responsible and motivated student ready to apply education in the workplace. Offers excellent technical abilities with software and applications, ability to handle challenging work, and excellent time management skills.
· Managed and updated the company's Safe Quality Food (SQF) system, including record-keeping, document control, verification, validation, and internal audits.
· Testing samples from production within the appropriate timelines.
· Participation in HACCP inspections (Good Manufacturing Practices) Collecting samples and precisely evaluating data and test results.
· Implemented and maintained Recall, Traceability, Sanitation, and Food Safety programs, ensuring product safety and quality.
· Examine completed processing and packaging batch records and related E-Data under defined protocols and customer specifications to fulfill departmental deadlines.
· Release completed goods in bulk and update the SAP system to facilitate additional packaging.
· Work on unique initiatives associated with the Continuous Improvement Plan of the Quality Department.
· Carry out related quality-related floor activities, such as reviewing production logbooks.
· Effectively implement a new document management system (DMS) across the organization, establishing uniform procedures for routine document review and updates
· Conduct quarterly audits to ensure document compliance with internal policies and external regulations.
· When necessary, create Work Instructions (WI) according to Standard Operating Procedures (SOPs)
· Move the SOP and WI material to the new Documentum template.
Workflow from SOP/WI to Documentum processed.
· To meet the Manufacturing Production Schedule (MPS) and Time Delivery (OTD) of QRs, generate the ARF/CoA based on the Quality Record (QR)/Change Control needs or new components requests.
· Examine, maintain, and update the ARF index database.
Gather data and information to prepare and build a data package in response to requests from Lab Operations.