Job Description:
- To issue the Batch Manufacturing Record, Equipment cleaning record, Logbooks, Analytical Report for raw material, finish product and packing material.
- Assistance in preparation of SOP of various departments/ preparation of draft SOPs.
- During plant round QA Executive to verify documents as per cGMP and GLP norms.
- Line Clearance activities for manufacturing and packaging before process starts.
- To issue the deviation form, Change control form, Out of Specification form, Customer complaint form, OOT form, investigation for etc. as per request from respective dept.
- Review and verification of Analytical and Batch Manufacturing Record and filing BMR. QA verification and release of finish product.
- To prepared documents & records and monitoring of activities as per SOPs
- Distribution, retrieval and control of SOPs,
documents/records of all dept.
- To participate the internal audits, customer audit, regulatory inspection.
- To Attend QR meeting as per schedule.
- To ensure data integrity as per procedure.
- To review manufacturing, store, QC activity.
- To prepare approved vendor list and maintain vendor qualification.
- Conduct traceability Activity.
- Preparation and maintain CAPA log.
- To ensure that deviations, product recall, return goods and customer Complaints, OOS, OOT by CAPA and Root Cause analysis are investigated, fill up of report and log the same.
- To collect data and prepare the annual product review.