AQA, Senior Executive - Sterile Injectable

Alembic Pharmaceuticals; Padra; On-site; INR 350,000 - 500,000; Full time

Job summary

Alembic Pharmaceuticals in Gujarat, India seeks a laboratory compliance specialist to oversee GMP adherence, inspection readiness, and quality systems at the site. You will review analytical data and instrument audit trails to ensure accuracy, traceability, and regulatory readiness.

The role involves electronic data verification, approval of method feasibility, verification, validation and transfer protocols, and maintaining calibration and maintenance schedules within the LIMS framework.

Responsibilities

• Ensure GMP compliance and inspection readiness at site.
• Review analytical data generated in the laboratory during testing.
• Review audit trails of QC instruments as per defined schedule.
• Verify electronic data generated during testing.
• Review and approve method feasibility, verification, validation, and transfer protocols, records and reports.
• Review calibration documents and certificates.
• Carry out laboratory activities through LIMS per procedures.
• Review Analyst Qualification data.
• Review chromatography data and perform electronic signatures.
• Review working standard qualification data.
• Review volumetric solution preparation, reagents, indicators, SST and colorimetric data.
• Review and approve stability summary reports.
• Review and approve calibration/Preventive maintenance schedules.
• Review calculation sheets.
• Create and review instrument methods in respective QC instruments.
• Perform all laboratory activities per SOPs, IOCPs and GTPs.

Job description

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.