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 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 ensure data integrity as per procedure.

? To review manufacturing, store, QC activity.

? To prepare approved vendor list and maintain vendor qualification.

? 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.

? To witness and verify of process validation, cleaning validation and equipment qualification

and to prepare protocol and report.

? Returned Material: Investigate and make investigation report and maintain the record.

? Product complaint: Investigate and make investigation report and maintain the record.

? Ensuring compliance of the systems used for maintaining the equipment and calibrating

equipment /instruments/ preparation of schedule.

? To prepare template or record format as per respected SOP and issuance.

? To prepare a schedule and conduct training on cGMP, GLP and evaluation of the training.

? Providing training to all concerned on cGMP and on job specific or based on needs identified.

? Any other assignment /work allocated by Head QA.

? To ensure disposal of waste is carried out as per procedure.

? To Support the head of department in the environmental management work and reporting to

head of Department regarding how the environmental management work is continuing.

? Investigation of deviation/ incident related to Environment management with co-ordination

with head of department.

Job Type: Full-time

Pay: ₹25,000.00 - ₹40,038.75 per month

Benefits:

Health insurance
Work Location: In person