- 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 secure 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.