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Qa Officer(qms)

4 weeks ago

Ankleshwar GJ IN Smart Tech Full time

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