Quality Engineer

J.D. for Q.A. For QMS  1) To maintain QMS Documents:  3.1 Preparation or drafting of new SOP & their index as per requirement & maintain review date.  3.2 Handling of Market Complaint: Acknowledge of Complaint, Log complaint in prescribe format,  participate in the investigation, evaluate the investigation findings and the corrective / preventive actions  proposed. Evaluate the risk and impact, maintain CAPA & periodic review to check effectiveness, maintain  complaint log & trend.  3.3 Deviation: Issue Deviation No., participate in the investigation, evaluate the investigation findings and  the corrective / preventive actions proposed (if required). Evaluate the risk and impact maintain CAPA &  periodic review to check effectiveness, maintain deviation log.  3.4 Change Control: Issue CC No., Verify whether the Change Control format filled is correct and all the  relevant information as necessary has been provided for evaluation, Identify the actions required as part  of impact assessment, Identify the departments from where evaluation of change is required and arrange  to forward the proposal to the concerned department for their evaluation/comments and acceptance,  maintain change control log & periodic review as per SOP.  3.5 CAPA: Issue CAPA No., identify the root cause, Implement corrective action, Verify effectiveness,  Analyze preventive action & Review for effectiveness.  3.6 Customer Audit: Acknowledge to customer or marketing team after receiving audit report, Circulate  audit report to concerned departments, Prepare reports of audit findings, submit Audit Compliance report  to customer with target date & review periodically for closer.  3.7 Internal Audit: Communicate with CQA for internal audit & audit finding. Maintain calendar, schedule  & observation report. Circulate observation report to concerned department & status update for audit  finding.  3.8 Assist to QA Head to change or new development required in SOP, STP, & Formats.  3.9 Fill Vendor Questioner form from marketing team & revert with documentation evidence.  3.10 Verification of Manufacturing Work Order.  3.11 Preparation, Distribution and Control of Master documents and records.