QA Executive (API/ Chemical)

Job Description:

RESPONSIBILITIES:
1. To issue the Batch Manufacturing Record, Equipment cleaning record, Logbooks, Analytical
Report for raw material, finish product and packing material.
2. Assistance in preparation of SOP of various departments/ preparation of draft SOPs.
3. During plant round QA Executive to verify documents as per cGMP and GLP norms.
4. Line Clearance activities for manufacturing and packaging before process starts.
5. 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.
6. Review and verification of Analytical and Batch Manufacturing Record and filing BMR. QA
verification and release of finish product.
7. To prepared documents & records and monitoring of activities as per SOPs
8. Distribution, retrieval and control of SOPs, documents/records of all dept.
9. To participate the internal audits, customer audit, regulatory inspection.
10. To Attend QR meeting as per schedule.
11. To ensure data integrity as per procedure.
12. To review manufacturing, store, QC activity.
13. To prepare approved vendor list and maintain vendor qualification.
14. Conduct traceability Activity.
15. Preparation and maintain CAPA log.
16. 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.
17. To collect data and prepare the annual product review.