SOP & Documentation Prepare, review and control laboratory SOPs. Check laboratory records, worksheets and logbooks. Ensure proper Positive Documentation Practices (GDP). Batch/Analysis Record Review Review QC test reports, analytical worksheets and raw data. Verify calculations, results and specifications. Review COA and related laboratory documents. Data Integrity Ensure ALCOA+ principles are followed. Check electronic and manual laboratory records. Monitor proper access control and audit trails where applicable. Deviation & OOS/OOT Review and monitor Deviation, OOS and OOT investigations. Check root-cause analysis and CAPA effectiveness. Ensure investigations are completed within timelines. Laboratory Compliance Conduct internal/self-inspections of QC laboratories. Verify compliance with GMP/GLP requirements. Monitor calibration and qualification status of instruments. Change Control & CAPA Review laboratory-related change controls. Track CAPA implementation and effectiveness.
Ensure approved changes are properly documented. Audit Support Support regulatory and customer audits. Provide required documents and records to auditors. Track observations and corrective actions. Training Ensure laboratory personnel are trained on SOPs, GMP, GDP and data integrity. Maintain training records. Environmental & Safety Compliance Monitor laboratory housekeeping and GMP practices. Verify proper handling and documentation of chemicals and samples
Pay: ₹30,000.00 - ₹45,000.00 per month
Advantages:
Commuter assistance
Versatile schedule
Health insurance
Internet reimbursement
Leave encashment
Life insurance
Provident Fund
Education:
Bachelor's (Required)
Experience:
Lab Qa: 5 years (Required)
Work Location: In person
📌 Lab Qa Executive Roorkee
🏢 rudransh group
📍 Roorkee
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