LYO Operator - Indore Plant

GUFIC BIOSCIENCES LIMITED; Bhat khedi; On-site; INR 450,000 - 750,000; Full time

Job summary

GUFIC BIOSCIENCES LIMITED in India seeks a Maintenance Engineer responsible for operation and maintenance and daily monitoring of utilities and process equipment, including lyophilizers.

You will review logbooks, manage PM schedules, prepare URS/PR/FAT/SAT/IQ/OQ/PQ documents, handle external service providers, and ensure compliance with cGMP and audit readiness.

Responsibilities

• Responsible for Operation & maintenance and daily monitoring of Utilities & Process Equipments (like Vial Line lyophilizers, etc.).
• Responsible for review the daily logbooks of utility, lyophilizers and process equipments and update all PM status label,
• Maintain the lyophilizes related all activities Operation, Maintenance, Cleaning & Documentation.
• Maintain the lyophilizes related all critical spares and consumable stock.
• Responsible for maintenance and troubleshooting of lyophilizer.
• Responsible for preparation of URS, PR and TR for lyophilizer etc. as per cGMP requirements.
• Responsible for preparation, Implementation and Compliance of all related SOPs.
• Responsible for preparation and handling of QMS documents (e.g. CCF, CAPA, Deviation, QRM etc.)
• Responsible for prepare the training schedule related SOPs and training shall be imparted to all concern department personnels and as well as external agencies (if required).
• Preparation of Preventive maintenance schedule of all equipment’s of Utilities, Process equipment’s etc.
• Timely execution of PM & attain all breakdown of lyophilizers, Utilities / Process / ETP equipment’s etc.
• Responsible for prepare PR & billing process.
• Responsible for fix the color coding identification of all piping & Labeling equipment’s. Fix the labels & display copy, Drawings etc.
• Responsible for Handling of external service provider agencies, preparation of technical agreement and Bill checking and processing.
• Responsible for identify and Implementation of energy saving activities.
• Maintain online documentation and follow the SOP’s.
• Responsible for always readiness for represent of facility / Equipments / Documents for MHRA/WHO/EU/USFDA etc. international and national audits & Compliances.
• Responsible for follow the HR/Admin, Safety (HSE), IT policies as per M/s. Gufic Biosciences Limited.
• Responsible for preparation of documentation & execution URS/DQ/FAT/SAT/IQ/OQ/PQ/CQ etc. of all equipment’s.
• Responsible to follow the safety rules and regulation & EHS department SOP’s. Issue the safety work permit to vendor before start the work. Ensure and wear safety PPE’s (as applicable) and Use the safe equipment’s, tools and tackles.
• Responsible for daily basis maintains the daily utilities consumption data.
• Responsible for preparation of annual budget for mechanical services & Spares for utilities equipment’s, lyophilizers, process equipment’s and maintenance of facility.
• Responsible for follow the entry exit procedure in classified areas.
• Responsible for all project related activities.
• Responsible for maintain the neat and cleaning of all areas and equipment’s
• Responsible for attain the any mechanical related work and breakdown.

Job description

Responsibilities

• Responsible for Operation & maintenance and daily monitoring of Utilities & Process Equipments (like Vial Line lyophilizers, etc.).
• Responsible for review the daily logbooks of utility, lyophilizers and process equipments and update all PM status label,
• Maintain the lyophilizes related all activities Operation, Maintenance, Cleaning & Documentation.
• Maintain the lyophilizes related all critical spares and consumable stock.
• Responsible for maintenance and troubleshooting of lyophilizer.
• Responsible for preparation of URS, PR and TR for lyophilizer etc. as per cGMP requirements.
• Responsible for preparation, Implementation and Compliance of all related SOPs.
• Responsible for preparation and handling of QMS documents (e.g. CCF, CAPA, Deviation, QRM etc.)
• Responsible for prepare the training schedule related SOPs and training shall be imparted to all concern department personnels and as well as external agencies (if required).
• Preparation of Preventive maintenance schedule of all equipment’s of Utilities, Process equipment’s etc.
• Timely execution of PM & attain all breakdown of lyophilizers, Utilities / Process / ETP equipment’s etc.
• Responsible for prepare PR & billing process.
• Responsible for fix the color coding identification of all piping & Labeling equipment’s. Fix the labels & display copy, Drawings etc.
• Responsible for Handling of external service provider agencies, preparation of technical agreement and Bill checking and processing.
• Responsible for identify and Implementation of energy saving activities.
• Maintain online documentation and follow the SOP’s.
• Responsible for always readiness for represent of facility / Equipments / Documents for MHRA/WHO/EU/USFDA etc. international and national audits & Compliances.
• Responsible for follow the HR/Admin, Safety (HSE), IT policies as per M/s. Gufic Biosciences Limited.
• Responsible for preparation of documentation & execution URS/DQ/FAT/SAT/IQ/OQ/PQ/CQ etc. of all equipment’s.
• Responsible to follow the safety rules and regulation & EHS department SOP’s. Issue the safety work permit to vendor before start the work. Ensure and wear safety PPE’s (as applicable) and Use the safe equipment’s, tools and tackles.
• Responsible for daily basis maintains the daily utilities consumption data.
• Responsible for preparation of annual budget for mechanical services & Spares for utilities equipment’s, lyophilizers, process equipment’s and maintenance of facility.
• Responsible for follow the entry exit procedure in classified areas.
• Responsible for all project related activities.
• Responsible for maintain the neat and cleaning of all areas and equipment’s
• Responsible for attain the any mechanical related work and breakdown.