Ankleshwar · Mid Level
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· Plant Engineer
· Carryout Periodic Preventive Maintenance.
· Carryout corrective Breakdown Maintenance as and when called for to restore proper functioning of the equipment in minimum time span.
· Make sure that to follow up all SOP’s related to Engineering.
· Maintain Good Housekeeping in Respective area.
· Assess the resource needs of the Department and Manpower.
· Validation Master plan to be followed.
· Implement, modification in facility & equipment’s as per business demand.
· Make sure that the Safety procedure followed.
· Make sure that CAPA are provided and implemented as when required.
· Make sure that the critical spares are maintained.
· Personnel responsibility shall be updated whenever change in designation / work nature / responsibility.
· Attending training programs as per the schedule provided.
· Make sure to verify the Technical Agreements with the service providers.
· Preparation and review of SOP’s of Engineering department and ensure its compliance.
· To coordinate for the preparation of Design Qualification, FAT, URS, Validation protocol, Qualification protocol and related formats/ documents of Manufacturing.
· To review the deviation / incidences, Change Control proposals for facility, equipment, equipment shifting and evaluate Validation / Qualification requirements through risk assessment.
· To coordinate during the External Inspection / Service agencies.
· Ensure that changes to the existing process/procedures/systems are implemented through change management procedure.
· Assessing the impact of the changes made in the existing procedure/process/systems through of the cross functional areas through review of the change control.
· To ensure that corrective and preventive actions are implemented within the defined timeline.
· Review and verification of all documents related to Engineering activities.
· To ensure self and other department associates adherence to use of PPEs as per safety norms.
· To follow the GMP, Safety norms and adhere to company’s policy, Quality policy, Safety and Environmental Policy.
· To operate various softwares namely TrackWise, Documentum, SAP, ZyTIMS for various QMS activities.
· To participate in the safety rounds, escalate the safety related incidents and perform required investigations and ensure implementation of the required CAPA for mitigation.
· To participate and represent Engineering in internal, customer and regulatory audits
· To ensure trainings requirements of the subordinates, allocation of the Job roles and Training need Identification and ensure the training fulfilments through ZyTIMS software.
· To Adhere with EHS improvement plan, to conduct safety talk, Tool Box talks etc. on the shop floor.
· Focus for improvement in day to day activity in compliance of cGMP and Safety.
· To have Awareness about Energy Conservation like Electricity, water, manpower etc.
· To delegate the activities to the respective deputy in absence.
· To escalate any issues related to discipline, availability of manpower, hygiene, contamination, cross contamination, Incidents or deviations, malfunctioning of equipment’s, any unusual observations, any safety risk or quality risk to next level or in absence further up.
· To perform any other activities as assigned by HOD after completion of the necessary trainings as applicable.
· Building and Maintenance Engineer
· Carryout periodic preventive maintenance.
· Carryout corrective breakdown maintenance as and when called for to restore proper functioning of the equipment in minimum time span.
· Make sure that to follow up all SOP's related to engineering.
· Maintain good housekeeping in respective area.
· Assess the resource needs of the department and manpower.
· Validation master plan to be followed.
· Implement, modification in facility & equipment's as per business demand.
· Make sure that the safety procedure followed.
· Make sure that CAPA are provided and implemented as when required.
· Make sure that the critical spares are maintained.
· Personal responsibility shall be updated whenever change in designation/ work nature.
· Attending training programs as per the schedule provided.
· Make sure to verify the technical agreements with the service providers.
· Preparation and review of SOP's of engineering department and ensure its compliance.
· To coordinate during the external inspection/ service agencies,
· Ensure that changes to the existing process/procedures/systems are implemented through change management procedure.
· Assessing the impact of the changes made in the existing procedure/process/systems through of the cross functional areas through review of the change control.
· To ensure that corrective and preventive actions are implemented within the defined timeline.
· Review and verification of all documents related to Engineering activities.
· To ensure self and other department associates adherence to use of PPEs as per safety norms.
· To follow the GMP, Safety norms and adhere to company’s policy, Quality policy, Safety and Environmental Policy.
· To operate various softwares namely TrackWise, Documentum, SAP, ZyTIMS for various QMS activities.
· To participate in the safety rounds, escalate the safety related incidents and perform required investigations and ensure implementation of the required CAPA for mitigation.
· To participate and represent Engineering in internal, customer and regulatory audits
· To ensure trainings requirements of the subordinates, allocation of the Job roles and Training need Identification and ensure the training fulfilments through ZyTIMS software.
· To Adhere with EHS improvement plan, to conduct safety talk, Tool Box talks etc. on the shop floor.
· Focus for improvement in day to day activity in compliance of cGMP and Safety.
· To have Awareness about Energy Conservation like Electricity, water, manpower etc.
· To delegate the activities to the respective deputy in absence.
· To escalate any issues related to discipline, availability of manpower, hygiene, contamination, cross contamination, Incidents or deviations, malfunctioning of equipment’s, any unusual observations, any safety risk or quality risk to next level or in absence further up.
· To perform any other activities as assigned by HOD after completion of the necessary trainings as applicable.
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