to Handle all Activities Related Quality Management System, Quality Assurance & Regulatory Affairs for
Technical Files Making & Updating Including Risk Management, Clinical Evaluation, Post Market Surveillance, Quality Plan, Esrs, Etc.
fulfilment of Regulatory Requirements Related to Ec Directive, Various Govt. Tenders & Registration of Overseas.
follow Up of Local Regulatory & Drugs Requirements.
validation- Machines, Processes, Clean Rooms, Material & Sterilization.
organizing Internal & External Audits Including Notified Bodies Audits Related to Quality Management System & Ce and Follow Up of Non-closure Reports.
dealing in Customer Complaints, Investigating, Root Cause Analysis and Replying, Vigilance Reporting & Recall.
mrm- Organizing & Follow Up Actions from Previous Meetings.
review & Modification in all the Sops & Manuals.
master List of Records- Establishment & Updating.
master List of Documents- Establishment & Updating.
deviations- Follow Up & Records
corrective & Preventive Actions- Corrections, Implementations & Maintenance.
calibration of Equipments and Machines of Production & Quality Control.
handling Out the Pre-dispatch Inspections of Shipments By the Outside Agencies and Certification Bodies.
training- Planning & Providing
Experience : 3 - 4 Years
No. of Openings : 1
Education : B.Sc
Role : Quality Assurance Executive
Industry Type : Hospitals / Medical / Healthcare Equipments
Gender : [ Male / Female ]
Job Country : India