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Lead-Facility Management(Biologics)

6.00 to 10.00 Years   Delhi   25 Jan, 2023
Sygene
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

    Operation and Supervision of Sterilization Autoclave and Decontamination Autoclave Monitor disinfectant preparation and ensure appropriate documentation Preparing daily routine facility cleaning disinfectant solution and ensure appropriate documentation. Supervise cleaning & sanitization of the clean rooms, maintain, and review the records. Facilitate and monitor daily availability of all the require material in clean rooms (Gowns, gloves, disinfectants etc.) as per the Standard Operating Procedures. Facilitate and monitor Waste management as per established procedures. Preparation of qualification documents URS, SLIA, Validation Plan, System Boundary, CLIA, DQ, RA, RTM, IQ, OQ and PQ and applicable deliverables based on qualification procedure. Lead and supervise operation of clean utilities and execution and documentation of qualification related to Facility Management. Monitoring and execution of routine Fumigation activity. Preparation and revision of SOPs related to facility and process equipments. Qualification, Requalification and Validation of Sterilization Autoclave, EMS and Clean Room equipment s. Preparation and revision of Forms and checklists and associated Facility Management documents in operations. Maintenance of quality records. Adherence to Standard Operating Procedures, Operational control procedures Verification of operations equipment calibration. Adherence to pollution control and safety requirements. Meet training requirements Ensuring readiness of prerequisites for batch activities Execution of manufacturing operations by adhering Syngene safety and GMP practices. Coordination with PPIC team and purchase team for Material requirement in Facility. Review of Environment monitoring data, online Environment monitoring trends reports and associated documents. Educational Qualification: BE/B.Tech/M.Sc/M.Tech in Biotechnology/Chemical Engineering/Microbiology Experience: More than 6-7 years of relevant experience Required Professional Skills and Capabilities:
    • Exposure on Autoclave validation Execution & Review / AHU Validation review / Cleaning Validation Execution & Review.
    • Person should have good QMS knowledge and work exposure.
    • Experience in NVPC monitoring in clean room facility.
    • Maintaining the cleanliness in the Cleanroom by ensuring cleaning activity & Fumigation activity. Take care of Garment Management.
    • Preparing & Review of the Risk Assessment / Impact Assessment / Investigation Report for facility related operations.
    • Coordination with Cross Functional Team for area clearance with respect to PM & Requalification of AHUs.
    ,

Keyskills :
continuous improvement facilitationstandard operating proceduresimpact assessmentpollution control

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