Job Description

Responsible to assist installation & commissioning of plant machinery. Responsible for qualification & documents related to qualification of plant machinery. Responsible for executing and installation of plant equipment's and monitor the site execution work in project. Responsible for maintenance and breakdown activity related to plant equipment / machineries. Responsible to procure & maintain the critical spares inventory. Responsible to update and maintain all cGMP documents related to breakdown & preventive maintenance of plant machinery as per SOP. Responsible to supervise the calibration activity and maintain the related documents. Responsible to generate tools and parts requirement for daily breakdown and preventive maintenance. Responsible to carry out all work as per cGMP and GEP. Responsible to update and maintain all cGMP documents related to breakdown and preventive maintenance as per SOP. Responsible for handling quality management documents i.e., Change control, Deviation, CAPA, Quality Risk Management etc.. Responsible for co-ordination with vendors and purchase department Responsible for qualification & documents related to qualification of plant machinery. To ensure that Preventive and Predictive Maintenance is carried out in co-ordination with the concerned departments as per planner. Preparation and review of QMS documentation. Skills
GDP


GEP


Maintenance skill for aseptic area & equipment for Pharmaceuticals products


Machine and instrument calibration


Good communication


Machine spares & vendor development



Education: Diploma/ B.E.


Total Experience - 3 - 7 Years of experience in engineering plant maintenance role for sterile manufacturing plant