Job Description

Role: Lead-Facility Management (Biologics)

Job Title: Junior Manager

Reporting To: Site Incharge

Job Location: Bangalore

About Syngene:

Syngene ( ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

Job purpose: Maintain compliance to current good manufacturing practices and keep facility ready all the times as per regulatory requirements. Responsibility to keep facility ready for audit

Responsibilities:

• 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 equipment\'s.
• 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 6-12 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 AHU\'s.

Syngene International