We are currently seeking a Quality Assurance Manager to organize arrangements made with the object of ensuring that all the quality required for their intended use and that quality systems are maintained.
Responsibilities
Responsibility to monitor all Production and Quality Control processes to identify areas of quality deficiencies. This includes from entry of raw material and packing material to exit of finished products in good condition.
Monitoring and coordination with production department to ensure regulatory compliance and proper execution of QA processes
Coordinate with procurement department to ensure quality of products viz lab kits/reagents, raw material and packing material.
To manage vendor qualification and quality agreements as per requirement of ISO 13485:2016 between supplier and user.
To ensure all documentation is being done on daily basis as per GMP/ISO/CE standards.
Assure that the requirements of master validation plan (MVP) are met.
To develop SOP for every activity, where deemed necessary, in collaboration with management, QC and Production managers.
Ensure that all the products are manufactured and packaged in full compliance with drug regulatory authority (DRAP), current Good Manufacturing Practices (cGMP), GLP and established SOPs.
To ensure that no compliance issue as per GMP/ISO/CE standards may be found during inspection.
Monitor laboratory activities to ensure compliance as per good laboratory practice (GLP).
To practically ensure that all lab equipment is working properly and proper calibration and standard solutions are being maintained.
