Experience

DD Enterprises

• India
• Biotechnology Research
• 100 - 200 Employee

• AGM - QA

  • Nov 2020 - Present

   Lead a team of CQV, QA, QC, and CSV.  Handling of FAT & SAT Qualification  Provide technical guidance into the commissioning Qualification and start-up of various pharmaceutical, Biopharmaceutical cGMP. Process equipment, utilities, & Facilities.  Lead the development of key Qualification deliverables such as DQ, FAT, SAT, IQ, OQ, & PQ during the project life cycle.  Conduct the Training program for CQV, QA, QC, and CSV Engineers/Specialists able to perform field execution of qualification test cases and protocols.  Development of Project validation plans (PVPs) to ensure the action plan to test the system is applicable and relevant.  Lead the qualification process throughout the project life cycle to ensure timely completion and ensure all the quality and engineering specifications are met.  Handling of CSV for process & automation systems.  Involved with other aspects such as client management (Maintaining key client relationships in support of business development and pursuit of new work) and project scheduling coordination of clients.  Handling of Deviations, Change Controls.  Review and Approval of SOPs related to cGMP.  Handling of ASME & ISO Audits



MICROLABS DE LA CUENCA

• Hospitals and Health Care

• Deputy Manager QA Validation

  • Jul 2012 - Oct 2020

   Preparation of validation protocols IQ, OQ, & PQ for Steam sterilizer, sterilization in place, terminal sterilizer, Dephyrogenaation tunnel, ampoules and vials washing machine, Filling machine, Pure steam generator, BOD Incubators, Stability chambers, VHP Decontamination pass box as per Current Regulatory Requirements and its execution.  Execution and Review of IQ, OQ, & PQ for Steam sterilizer, sterilization in place, terminal sterilizer, Dehydrogenization tunnel, ampoules and vials washing machine, Filling machine, Pure steam generator, BOD Incubators, Stability chambers, VHP Qualification Activities as per validation Master plan  Steam sterilizer Load pattern designing, and Cycle developments based on the FDA, PDA & ISO, EN285 Requirements.  Routine steam Quality test to be carried out as per EN285 Requirements  Protocol Preparation and Execution of Temperature and Relative humidity mapping study protocols for Storage areas and project areas and its execution as per current Regulatory requirements.  Preparation and Execution of URS, Design Qualification, FAT Installation Qualification, Operational Qualification, Parameter development study and Performance Qualification For all Equipment’s.  Execution of Calibration for instruments in the plant by external agencies as per calibration planner to ensure the instruments are within the Calibration due period for safe and trouble-free operations of the equipment and verification of calibration reports.  Preparation of Calibration schedule as per Validation master plan (VMP) for critical and non-critical instruments and measuring devices,  Preparation of Preventive maintenance schedule as per Validation master plan (VMP) for all equipment’s from time to time.  Daily monitoring of Stability Chambers, Microbiology temperature monitoring equipment’s  Handling of Deviations, Change Controls regarding to equipment’s qualifications.



MICROLABS LTD.

• Bangalore Urban, Karnataka, India

• Executive - Instrumentation

  • Feb 2010 - Dec 2011

  EQUIPMENTS HANDLE – MICROLABS:  Autoclave  Fedegari, Metal chem, Pharma lab & Machine fabric.  Bio process equipment’s  DD Enterprises, Adam fabriwerk.  Filling Machine  Groninger, Rota & Rommelog  GEA High pressure Homogenizer  VHP Decontamination pass box. (Bioquel)  Pure Steam Generator. Pharma lab  Nitrogen generator.  Steam Quality test kit (SVMS)  Ellab Dataloggers –, Ebro Dataloggers for Thermal validation (21 CFR Part 11 Compliance)



Servewell Instruments - India

• Biotechnology Research
• 1 - 100 Employee

• Commissioning & Qualifications Engineer

  • Apr 2005 - Jan 2010

   Nature of Work: Commissioning and Qualification of equipment’s, Installation, Service, Preventive maintenance, Performing IQ / OQ & PQ of equipment’s, Preparation of SOP’s, Training to the users about the care & maintenance of the instruments. Performing IQ/OQ/PQ Validation & generating the reports according to International Standards.  Instruments and equipment’s Handled:  PH meters & Conductivity meters (Indigenous & Imported)  Water Baths (All types)  Hot Air Oven / Bacteriological Incubators / Bio Oxygen Demand Incubators  Moist Air Sterilizers / LAF Cabinets / Colony Counters  Antibiotic Zone Readers, Media Dispensers (Peristaltic Pump)  Stability Chambers / Photo Stability Chambers / Vacuum Ovens (Thermo lab equipment’s Pvt. ltd and Newtronics equipment’s)  Dissolution Test Apparatus / Friability Test Apparatus / Disintegration Test Apparatus  Bulk Density Test Apparatus / Electromagnetic Sieve Shakers  Peristaltic Pump for Tablet Coating  High Pressure Autoclaves (Hydrogenators / Rocker Shaker) s