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 • Experienced in preparing SOP, EOP, concept note, Study Protocol and QMS documents. • Subject Matter Expert (SME)for micro-related equipment qualification during internal and external Audits. • Experienced in preparing SOP, EOP, concept note, Study Protocol, and Quality Management Systems (QMS), in carrying out an investigation, analyzing the impact anticipated due to the non-conformance, performs risk assessment using Track Wise system. • Support qualification/ AMC activity remotely by OEM.

• 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. • Handle with vendor /OEM of Equipment for breakdown/troubleshooting, calibration, PM, and Annual Maintenance Contract (AMC) • Prepare SOP, EOP, concept note, and Study Protocol • Perform annual requalification activity for thermal and process-based equipment • Maintaining calibration and preventive maintenance tracker and ensuring all are maintained accordingly. Involve in fumigation activity.

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 • Perform fumigation and de-fumigation • Checking Liquid Nitrogen (LN) level and storing harvest cells in LN