Calibration of the entire field related instruments as well as on new instrument & ensure the schedule date of calibration done as per schedule. • To comply internal/ external GMP and Regulatory audit observation throughout the department. • To perform Engineering documentation activities like SOP trainings, calibration and requalification. • To perform the validation, qualification, requalification activities like machine, equipment and area assist the QA team. • Coordinate with the external agencies and vendors for scheduling of work inside the factory premises. • To coordinate the QMS (Quality Management System) and to comply throughout department facility u[gradation related document activity like initiate change control, QRM, CAPA, Deviation, Preparation of SOP, facility, Layout, etc. • To regulatory review the routine operations and maintenance respective records for updating of online, GMP & GEP practices. • To handle archive and retrieval procedure of engineering log books and controlled documents. • To update, issuance & rectification of document like SOP’s logbooks, Preventive Maintenance schedule,, calibration schedule, and equipment list • Provide recommendation, modification & improvements to existing systems. • Contribute to projects to develop new or improved processes and innovations.
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