Implementation and improvement in Quality Management System as per ISO 13485:2016.
Implementation & Formation of Standard Operating Procedure (SOP) & Protocols as per GMP.
Maintain complete documents of various departments like Site Master File, Device Master File with easy archival/retrieval.
Involve onsite into the calibration & Validation activities. Preparation of Calibration calendar and preventive maintenance.
Assist in preparation of Batch Manufacturing Record as per manufacturing and their review before release of the batch.