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.