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Vijayakumar Muniraj

Vijayakumar Muniraj

Commissioning and qualification

Pharmaceutical / Bio-tech

Johor Bahru, Johor

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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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