Job Description

Role & responsibilities BE Electrical /Electronics/ Instrumentation: Responsible for monitoring of water system SCADA , Pretreatment water system , Purified water generation , WFI generation and distribution system , Pure steam generation and distribution system. Monitoring of EMS and BMS system To ensure differential pressures, temperature & Relative Humidity of classified areas within pre-determined limits. Supervise all vendor activities and verify all tests performed by them in clean room validation/variable refrigeration flow air conditioning systems. Authorized to review all documentation of HVAC activities in logbooks, log sheets, AHU filter cleaning records & FMS alarms summary, Qualification Documents of HVAC System. Responsible for AHU qualification / re-qualification & related documentation including in-house & out-sourced testing. Preparation / revision of SOPs for HVAC operations as well as GMP training related to HVAC. To initiate & filled the change control, Deviation & CAPA for HVAC section with coordination of QMS related to Projects. Responsible to Execution of Clean room and HVAC Project with Co-Ordination of Outsourced/Third party. Responsible for Purchase Requisition initiation for consumables. Managing communication with respective Outsourced/Third party vendors and provide support to all project and processes. Provide support to all Breakdown and preventive maintenance requests, Manage all communication and provide efficient feedback for all project activity To Provide Support to engineering department during the period of Plant Audit. To enrol engineering HVAC staff in all trainings in GMP and technical knowhow as and when it is conducted To follow Good Documentation Practices and Data Integrity requirements during any GxP Operation and recording at site. To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed. To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP data (Records, Reports) specific to Job description. To ensure that, in case of any event of potential data breach, it shall be handled through SOP on Handling of Potential Data Integrity Observation. BE Mechanical: Responsible for monitoring of water system SCADA , Pretreatment water system , Purified water generation , WFI generation and distribution system , Pure steam generation and distribution system. Monitoring of EMS and BMS system To ensure differential pressures, temperature & Relative Humidity of classified areas within pre-determined limits. Supervise all vendor activities and verify all tests performed by them in clean room validation/variable refrigeration flow air conditioning systems. Authorized to review all documentation of HVAC activities in logbooks, log sheets, AHU filter cleaning records & FMS alarms summary, Qualification Documents of HVAC System. Responsible for AHU qualification / re-qualification & related documentation including in-house & out-sourced testing. Preparation / revision of SOPs for HVAC operations as well as GMP training related to HVAC. To initiate & filled the change control, Deviation & CAPA for HVAC section with coordination of QMS related to Projects. Responsible to Execution of Clean room and HVAC Project with Co-Ordination of Outsourced/Third party. Responsible for Purchase Requisition initiation for consumables. Managing communication with respective Outsourced/Third party vendors and provide support to all project and processes. Provide support to all Breakdown and preventive maintenance requests, Manage all communication and provide efficient feedback for all project activity To Provide Support to engineering department during the period of Plant Audit. To enrol engineering HVAC staff in all trainings in GMP and technical knowhow as and when it is conducted To follow Good Documentation Practices and Data Integrity requirements during any GxP Operation and recording at site. To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed. To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP data (Records, Reports) specific to Job description. To ensure that, in case of any event of potential data breach, it shall be handled through SOP on Handling of Potential Data Integrity Observation. BE / Diploma in Instrumentation Engineering: Responsible for maintenance of water system SCADA , Pretreatment water system , Purified water generation , WFI generation and distribution system , Pure steam generation and distribution system. Maintenance of EMS and BMS system To ensure differential pressures, temperature & Relative Humidity of classified areas within pre-determined limits. Supervise all vendor activities and verify all tests performed by them in clean room validation/variable refrigeration flow air conditioning systems. Authorized to review all documentation of HVAC activities in logbooks, log sheets, AHU filter cleaning records & FMS alarms summary, Qualification Documents of HVAC System. Responsible for AHU qualification / re-qualification & related documentation including in-house & out-sourced testing. Preparation / revision of SOPs for HVAC operations as well as GMP training related to HVAC. To initiate & filled the change control, Deviation & CAPA for HVAC section with coordination of QMS related to Projects. Responsible to Execution of Clean room and HVAC Project with Co-Ordination of Outsourced/Third party. Responsible for Purchase Requisition initiation for consumables. Managing communication with respective Outsourced/Third party vendors and provide support to all project and processes. Provide support to all Breakdown and preventive maintenance requests, Manage all communication and provide efficient feedback for all project activity To Provide Support to engineering department during the period of Plant Audit. To enrol engineering HVAC staff in all trainings in GMP and technical knowhow as and when it is conducted To follow Good Documentation Practices and Data Integrity requirements during any GxP Operation and recording at site. To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed. To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP data (Records, Reports) specific to Job description. To ensure that, in case of any event of potential data breach, it shall be handled through SOP on Handling of Potential Data Integrity Observation.