Job Description
– To ensure strict compliance of the Quality Management System (QMS) to current requirements of national, international standards and regulations.
– Support Quality Head in QMS and its effective implementation
– Through knowledge on ISO 13485:2016, ISO 14971:2019, Medical device rule 2017 and IVDR
– Administration of quality assurance function (documents control, issuance, retrieval and record)
– Ensure implementation of GMP & GDP
– To develop, implement and approve Quality Assurance procedures and policies.
– To effectively monitor and ensure proper functioning of quality tools such as Deviation, Change control, Incident, etc.
– To monitor activities of in process quality assurance and Lab quality assurance
– To prepare and review APQR (Annual Product Quality Review)
– Ensure customer complaints are effectively handled as per SOP.
– Coordinate Batch failure and OOS Investigations ensuring appropriate Corrective and Preventive actions (CAPA)
– Check & review SOP’s, VMP, SMF, Quality Manual, QMS documents & addition or deletion of documents as per requirements
– Conduct internal training programs for all the departments on QMS, GMP and GDP
-Team handling and team Training
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