Gobishankar Perthabalakshmishkar Email & Phone Number

Singapore

Singapore, Singapore

Johor Bahru, Johore, Malaysia

• Commissioning, qualification of pharmaceutical manufacturing equipment (e.g., Isolator, Autoclave, Incubator, Oven, and Lab Equipment /Instruments), and computerized system validation (CSV).
• Validate the equipment as per the specification and challenging test activity to meet Guidelines & standards.
• Preparing the documents for Equipment validation (DQ, IQ, OQ, PQ) and annual requalification using Val Genesis (VLMS).
• Review of Biological Indicators (BI) test report, including population assay verification and Microbial identification for newly received BI.
• Part of the project team, for the expansion of new micro lab, modification of existing lab, decommissioning of malfunction equipment, and implementation of new software such LIMS, PROCAL5, Val Genesis (VLMS)
• Reviewer for equipment/instrument related qualification and smoke study activity for cleanroom area and micro equipment with HEPA

• Maintain the micro laboratory facility in optimum condition and coordinate with the facility maintenance team if any issue is observed.
• Performing Lab monitoring (Relative Humidity, Temperature, and Differential Pressure, manual temperature monitoring for lab equipment, Passbox UV monitoring, and lab cleaning activity).
• Monitoring Cleanroom parameters and AHU using QBMS system.
• Perform time synchronization for all standalone systems.
• Handling of Biological Indicators, including exposed BI for inoculation. (E.g., Strips, Disc, and Ampoule)
• Perform Visual Inspection for media fill batch.

Johor, Malaysia

• Performing Lab monitoring (Relative Humidity, Temperature, and Differential Pressure, manual temperature monitoring for lab equipment, Passbox UV monitoring, and lab cleaning activity).
• Assist in preparing SOP, EOP, concept note, and Study Protocol.
• Perform water sampling for (Process Water, Purified water, WFI, and Pure Steam Condensate).
• Assist in obtaining data and supporting evidence for the non-conformance investigation and CAPA
• Handling of decontamination cycle for biological waste.
• Prepare the load material for the requalification activity.

Kota Damansara

• Environmental monitoring (Active and Passive sampling)
• Preparing in-house media plates for (finger dap, sample, and for environmental monitoring)
• Observing plates for microbial growth
• Perform cell counting
• Prepare antibody for Fluorescence-activated cell sorting (FACS) for whole blood, Natural killer cell, and T- cell and for mesenchymal stem cells (MSC).
• Using differential kit for MSC