About this role
- 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