AQA, Senior Executive - Sterile Injectable

JOB RESPONSIBILITIES :

• To ensure GMP compliance, Laboratory compliances and inspection readiness at site.
• Review of all Analytical data generated at laboratory during testing.
• Review of audit trail of QC instruments as per define schedule.
• Verification of electronic data generated at laboratory during testing.
• Review and approval of Method Feasibility / Verification / Validation / Transfer protocol, Record of analysis and reports.
• Review and approval of Calibration documents, Certificates.
• Carry out laboratory activities through LIMS software as per relevant procedure.
• Review and approval of Analyst Qualification data.
• Review of chromatography data and perform electronic signature.
• Review of working standard qualification data.
• Review of volumetric solution preparation, reagent, Indicator, SST solution and colorimetric solution data.
• Review and approval of Stability summary report.
• Review and approval calibration/Preventive maintenance schedule.
• Review and approval calculation sheets.
• Create and Review of Instrument method in respective Quality control Instruments.
• To perform all laboratory activities as per existing SOPs, IOCP’s and GTP’s.