supported toSupported writing and investigateinvestigating OOS, Corrective Action and, Preventive Action, and co-ordinatecoordinated to develop a strategy for implementing CAPA action to achieve desired outcomes.
• Provide• Provided assistance in writing and implementing SOPs and; revised SOP to support Quality Operations.
• Assisted in writing change control, deviation, and incident reportreports to support document changes and minimized chancethe chances of unauthorized activities.
• Filled over 30 vendor qualification forms and resolution queries received from customercustomers and customercustomers' complaints.
• Collected data and prepareprepared an Annual Product Review of 17 products per assigned schedule and set trend of yield, analytical result, and product manufacturing parameters.
• Revised over 100 specifications and standard testing procedures from respective pharmacopoeia (USP, BP, Ph. Eur, IP).
• Authorized for distribution, retrieval, and traceability of the appropriate department’s logbooks and documents; achieved document tracking every four months.
• Attended audit close-out meetings and Coordinatedcoordinated audit findings-responsesfindings/responses as applicable.
• Provided support for over 100 product stability testtests, summarized stability data, and verified CoA of finished product.
• Working knowledge of GMP, GLP, GDP, regulatory, and corporate guidelines.
• Performed and analyzed oral formulations, responsible for In-process Testin-process test (pH, hardness, dissolution, visual clarity, leak test, average weight, friability).
• Examined production stages and was accountable for line clearance at every stage and keepkept records and documentation as per GMP guidelines.
• Developed Batch Manufacturing Record, Batch Packaging Record, Validation Protocols, and execution of other GMP Documentsdocuments.
• Verified test results and Communicatedcommunicated with other departments to ensure there were no delays in production.
• Conduct• Conducted on-site job training for three junior employees, Participatedparticipated in a GMP training program to giveenhance staff skill and competence; Recordrecorded all training assessments.
• Sampling• Operated sampling and Testingtesting of raw material tointo finished product and Calibration ofcalibrated laboratory instruments according to procedure defined by SOPs.