01 Oct
|
rudransh group
|
Roorkee
01 Oct
rudransh group
Roorkee
SOP &
• Documentation Prepare, review and control laboratory SOPs. Check laboratory records, worksheets and logbooks. Ensure proper Valuable 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
Benefits
- Commuter assistance
- Flexible 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