Urgently required experienced Quality Assurance Executive for Okhla, Delhi Location
Descripción del trabajo
To handle all activities related quality management system, Quality Assurance & regulatory affairs for ISO 9001 & 13485, 93/42/EEC Directive including-
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 nonclosure 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 equipment’s and machines of production & quality control.
Handling out the pre-dispatch inspections of shipments by the outside agencies
Experience in medical devices
Required Experience and Qualifications
Education- B.Sc. degree, masters may be preferred.
Experience 3-4 years as a Quality Assurance executive in medical devices/pharmaceuticals
Tipo de empleo
Experiencia laboral (en años)
3 - 4
Okhla phase 2, Delhi