Job Description
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Responsible to assist installation & commissioning of plant machinery.
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Responsible for qualification & documents related to qualification of plant machinery.
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Responsible for executing and installation of plant equipment’s and monitor the site execution work in project.
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Responsible for maintenance and breakdown activity related to plant equipment / machineries.
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Responsible to procure & maintain the critical spares inventory.
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Responsible to update and maintain all cGMP documents related to breakdown & preventive maintenance of plant machinery as per SOP.
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Responsible to supervise the calibration activity and maintain the related documents.
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Responsible to generate tools and parts requirement for daily breakdown and preventive maintenance.
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Responsible to carry out all work as per cGMP and GEP.
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Responsible to update and maintain all cGMP documents related to breakdown and preventive maintenance as per SOP.
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Responsible for handling quality management documents i.e., Change control, Deviation, CAPA, Quality Risk Management etc..
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Responsible for co-ordination with vendors and purchase department
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Responsible for qualification & documents related to qualification of plant machinery.
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To ensure that Preventive and Predictive Maintenance is carried out in co-ordination with the concerned departments as per planner.
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Preparation and review of QMS documentation.
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Skills
GDP
GEP
Maintenance skill for aseptic area & equipment for Pharmaceuticals products
Machine and instrument calibration
Good communication
Machine spares & vendor development
Qualifications
Education: Diploma/ B.E.
Total Experience - 3 - 7 Years of experience in engineering plant maintenance role for sterile manufacturing plant