• Wrote, performed, reviewed and executed IQ, OQ and PQ Validation protocols of Wide Web SATO (CL4NX and M10e thermal transfer ) Printers and LVS Vision System • Hands on with LVS 7500 Vision System Software, Microscan Barcode Verifier (Integra 9500 software), Print On Demand Software (By Abbott)• Work closely with other team members and departments that will be authoring SOPs and Batch Records for the same equipment • Collaborated with vendors to obtain required trainings, any information needed to properly document, operate and test machines• Handled various situations and troubleshooting for the equipment operations by contacting the manufacturers/vendors when needed• Engaged in various site-specific trainings and trained technicians and operators on the printers and vision system• Engaged in Qualification/Validation of Printers on the facility

Supporting Stantec's Projects

Supporting various Stantec's Commissioning and Validation projects for Pharmaceutical companies

• Assisted with development of validation protocols, performs testing and writes validation reports for various equipment manufacturing processes, and products in adherence to DEA, FDA, cGMP and 21 CFR 11 requirements• Authored, performed, reviewed and executed various types protocols of Vial Washer, Isolator containment system under the direction of the Site Validation Manager• Primary support for validation of automated Filling lines • Developed Verification/Qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports• Assisted for the validation/verification protocol execution for Depyrogenation Tunnel, Lyo Filler, Lyo capper and other protocols for utilities like Nitrogen, Clean room

• Assisted with development of validation protocols, performs testing and writes validation reports for various equipment manufacturing processes, and products in adherence to DEA, FDA, cGMP and 21 CFR 11 requirements• Wrote, performed, reviewed and executed various types protocols of basic processing/packaging equipment and processes under the direction of the Validation Manager• Primary support for validation of automated packaging lines for Blow Fill Seal, ophthalmic products to commercial operation and maintenance phase • Experience with automated equipment like PLC/HMI controlled systems, robotic and servo-pick-and-placement, cartoner, printers, temper sealer, checkweigher, case packer and labeler• Experience using electronic document management system – ENNOV-DOC-EDMS, Simplicit-e• Developed Verification/Qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports• Assisted for the Cleaning validation/verification protocol execution• Hands on experience with the visual inspections, rinse samplings and Swabbing to support cleaning validation/verification • Responsible for the label design and database accuracy of packaging barcodes for the company and its OEMs• Provided technical assistance with regard to validation issues to the process engineering department.• Assisted with the development of the FRS, URS, Risk assessment(FMEA), SOPs • Experienced/certified with aseptic techniques and ISO7/ISO 8 (Aseptic clean room Class 100) gowning

Perform technical process operations for developmental lots,executing process unit operations including: tangential flow filtration, centrifugation (continuous and batch), virus inoculation and propagation, and sterile filtration.Experience with biopharmaceuticals, vaccines process development, or laboratory scale execution of tangential flow filtration, centrifugation (batch and continuous), cell culture Experience using electronic document management system - eDocs Worked in various studies that requires the production of Influenza vaccine Prepared Inoculum for the egg inoculation Experience with set up, operation, cleaning and maintenance of candling of embryonated chicken eggs for Influenza virus vaccine Performed harvest operation and cleaning of the harvest machine Experience with set up, operation, cleaning and maintenance of 8 micron filtration system, Rame Hart Egg incubator Hands on experience with assembling, cleaning, sanitizing, use and storage of 300 kDa and 50 kDa Tangential Flow Filtration (TFF) system Cleaning of equipment’s like Tanks, canisters, small parts, centrifuge tubes Prepared, build and wrapped disposal manifolds for sterilizing autoclave Handled disposal containers for Bio-hazard materials Used pH meter, heating plates, mixer to prepare the buffers Used and operated bio-chemical fume hood and bio safety cabinet

Client: Glenmark Pharmaceuticals North Carolina , USAAssisting a team for various validation projects for execution of IOQ for the protocols.

● Performed equipment validation of Steris autoclave, Terminal sterilizer, Automatic Vial loading and unloading, vial capping● Performed and qualified Installation Qualification and Operational Qualification of the equipment’s● Facilitated major component verification used in equipment● Performed temperature mapping of the autoclave● Piping installation and material verification

Developed and validated a cleaning process for commercial productsPrepared and tested standards during development of cleaning processConducted a GMP internal audit of the SPRC and its projectsPerformed Design of Experiments (DoE) using Minitab 16 to determine worst case scenarioPerformed risk assessment using FMEA technique, root cause analysis, OOS Investigation, CAPA

• Worked In Osaka Pharmaceuticals (Vadodara, India) in Production Of Capsules And Dry Powder Production.• Wrote The Batch Manufacturing Records (BMR) For The Capsule Productions.• Helped To Maintain The Cleaning Records And Log Books.• Observed Health Standards While Performing Procedures.• .Performed the evaluation Of the In-process Batches