QA Officer

Tabuk Pharmaceuticals Manufacturing Co

Conduct product test according to SOP (Standard Operating Procedures).

• Perform processing & calibration of quantitative solution & prepare reports consequently.
• Provide accurate and concurrent laboratory results using data capture forms and laboratory Information management system.
• Perform material analysis process according to SOP & use the operational evidence for the laboratories testing implementation.
• Participate in trouble shooting and test problem resolution.
• Prepare daily reports throughout the operational stages & make sure that they are delivered to concerned department.
• Conduct routine equipment monitoring.
• Prepare Quality Control analytical documentation and reports.
• Understand and follow cleaning and disinfection procedures for all work areas.
• Initiate preparation & standardization of volumetric solution, test the solution and document every report and finding.
• Record analytical findings in the test respective logbook and confirm the calculation by updating it in SAP.
• Prepare approved labels for various stages of operation.
• Monitor temperatures in QC laboratory & make entry from time to time.
• Anticipate calibration and verification of QC instruments & QC balance regularly along with cleaning validation.
• Prepare COA for raw material, stability, packaging & finished goods.
• Notify supervisor of any deviation from set norms.
• Follow rejection procedure as per SOP.
• Perform sample testing, analysis & report preparation for water used for injection (Purified & Raw Water).
• Follow the documentation system requirements along with CGMP, GDP, GLP & EHS precautions.
• Set stability study samples & monitor stability chamber regularly.
• Formulate Raw Material Data Sheet (RMDS) by entering tested data.
• Perform standardization against reference standards as per valid approved test procedure.
• Report specifications like OOS/OOT if any.
• Ensure confidentiality of all documents and information related to work.