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 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.
