AQA - GLP

Role & responsibilities

• well known about regulatory requirement
• Ensure the laboratory cleaning procedure daily
• Knowledge of cGMPs, USP, and FDA (21 CFR Parts 210 and 211) regulations
• Good exposure in QC Instruments calibration as per SOPs
• Review of QC instrument/ Equipments SOPs
• To ensure GDP & GLP are followed in QC chemical laboratory
• Exposure into the QC sophisticated instrument like HPLC, GC, IC, UPLC, Dissolution, IR, UV spectrophotometer
• Knowledge about the analytical method transfer and analytical method development
• Knowledge about QC all instruments with software
• Review audit trail of server based instrument (21 CFR)
• Working standard/ primary standard/ reference standard consumption record verify
• Verify the Impurity solution preparation record with appropriate storage condition
• Strong prioritization, organizational skills and detailed oriented
• Verify the calibration status of all the QC instrument daily 
• Review the usages glassware as per regulatory requirement with certificates
• Responsible for carrying out audit management of the Quality control Department. To provide work progress of the department to the management as when required

To review the non-critical instruments (i.e. Oven, Sonicator, Media degasser, Centrifuge but not limited to.,) calibration/ verification and preventive maintenance records