About Vijayakumar Muniraj:
➢ SME for engineering department.
➢ Handling of Regulatory and Client Audits from Engineering.
➢ Plant maintenance and project management for biopharmaceutical and pharmaceutical equipment’s and facility.
➢ Designing of pharmaceutical injectable and OSD facilities from conceptual to detail engineering stage.
➢ Strategy decisions of engineering outsourcing and people management.
➢ Driven and Implemented SAP plant maintenance (Corrective and preventive) module and Calibration module.
➢ Facility Qualification and Qualification of equipment’s by referring the regulatory guidelines such as ISO, PIC, FDA, WHO, MHRA, EMA, ISPE and USP, which includes HVAC/Purified water /WFI/Pure steam/compressed air/nitrogen gas /Autoclave / Formulation vessels/Tunnel/Combi Filling line /Isolator /Environmental controlled equipment’s and areas.
➢ Design, Installation, Commissioning and qualification of clean utilities such as HVAC, Water as well as process equipment’s such as Formulation vessel, Combi Filling machine, Isolator, Tunnel, Lyophilizer, Fermenters.
Experience
Biocon sdn bhd , Malaysia , May-2018 to until now
ApoteX Research pvt lte , india , Mar-2012 to May-2018
Micro labs limited, india , Sep -2008 to Mar-2012
Education
BTech - Electronic and communication
Diplamo in Electronic and communications
MBA - under progress
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