 Leading Sterility assurance: Management of aseptic process simulation program (Media fill) for Generic injectable & complex injectable facility. Operational Quality Assurance: Management of compliance at shopper floor throughout the batch manufacturing process. Process validation and continuous process verification. Quality Compliance / Microbiology QA: Review & approval of analytical Microbiology documents (Method validation, microbiological Trends, QRM, analytical documents). Review & approval of Change request (CR) & SOP (D2 Documentum) and management of overall Microbiology compliance. QMS: Responsible for review & approval of QMS document (Incident, CAPA, OOL, OOS, Change control) related to microbiology and manufacturing process. Investigation & effective implementation of CAPA for continual improvement in Quality system. Handling of Quality Risk Management related to process and Microbiolgy. Batch release: Ensure timely release of batch with compliance to achieve the business requirement. Equipment & Utilities Qualification document review & approval. Audit & compliance: Regulatory Inspection management –ensure readiness of site for inspection, coordinating with inspector, site Audit management, involve in preparation of response or compliance to regulatory authorities inspection observation and closure.Involved in preparation of query response like IR, DRL, CRL received from USFDA and other regulatory agency.

Sterility Assurance QA, Management APS (Media fill), QMS , Audit compliance, Microbiology compliance, Handling of Audit.

Working in Green field project for parental Drugs @ Lupin Pharmaceutical Ltd, Nagpur. Sterility assurance: Managing of aseptic process simulation program (Media fill) and implementation of media fill program at green field project. Lead operational QA (IPQA): Management of overall quality assurance activity at manufacturing shop floor with coordination of team member and other cross functional team. Management and handling of Process Validation and cleaning validation at shop floor.  Visual inspector qualification & management of visual inspection & packing process Quality Compliance / Analytical QA: Review & approval of analytical Microbiology document.  CQV: Equipment & utility qualification document for green filed project and management of Microbiology compliance. CSV: Review & approval of the computer system validation documents with Computer System impact assessment, GxP assessment with GAMP categorization. Review & approval of EDC/VPP/ FRS/ FRA/IQ/OQ/ PQ – Test Script & report & SRC. QMS: Responsible for management of QMS (Change control, deviation, CAPA, LIR, OOL) activity related to Microbiology (OOS related to Water / Endotoxin/ Sterility / Bioload) and manufacturing process. Qualification of equipment’s / instruments, utilities - Green field project.

1. Responsible for LAB QMS. Review of analytical report (QC / Microbiology) for meeting compliance with current regulatory requirement2. Handling of Quality Risk Management (QRM).3. Review and approved of SOP, Qualification Protocol, Method Validation Protocol.4. Review of BMR, BPR and batch release. Actively involve in simulation trial.5. Aseptic area audit in manufacturing area, Microbiology, QC relevant Dept and Real time/CCTV monitoring of aseptic behavior during batch manufacturing.6. Line clearance during manufacturing activity.7. Conducting audit.8. Conducting training for better understanding of procedure.9. Conduction training program.

Responsible for:Managing Method validation, Deviation, Change control, STP / Specification and other relevant activities.  Coordinating with R&D, RA, and Quality & Manufacturing Department for smooth information flow related to Microbiology.  Review of regulatory submission document. Responsible for Preparation of SOP/GTP/STP/Specification and their implementation for continual improvement. Responsible for effective completion of Microbiological Validation program for all Technology transfer product to support the business goals.  Responsible for effective review of method Validation document. Responsible for handling of Change control. Responsible for Initiation of the Deviation/Exception and Successful completion of Investigation. Implementation of CAPA based on the nature of Deviation/ Exception or event and completion of the CAPA. Defining project scope, goals and deliverables that support business goals. Bioburden method validation protocol preparation for Raw material, bulk solution (In Process). BET Method validation protocol preparation for Raw Material, in-process and Finished product by Gel Clot, Kinetic Turbidimetric/ Kinetic Chromogenic Assay Method. Sterility Test method validation Protocol preparation for Finished product. Method validation (BET/Bioburden/Sterility) analysis execution as per the approved protocol and effective completion of the validation program. Antimicrobial Effectiveness Test Validation for Parental Drugs.Supportive Role: Isolation, identification of microorganism using VITEK-MS and BBL Crystal Autoreader.  Micro challenge study & Container closure Integrity Study. Handling audits conducted by International regulatory bodies- US-FDA

• Media Preperation & Media stock maintenance• Water Analysis• MLT• Planning & Handling of day to day lab activities Environment monitoring of lab & manufacturing area .Inoculum development: Inoculum development for the recombinant strains used for the manufacture of biologicals.Products: Insulin & Insulin analogs, recombinant streptokinase, recombinant human granulocyte colony stimulating factor.Inprocess control: Inprocess checks of the lab and fermenter stages and their clearance.Production Process control : Production process control incordination with productionFilter integrity testing :Testing of filters used in the biological manufacturing processDocumentation: Preperation, review and maintenance of Quality control records.preperation and review of protocols and reports. Documentation of activities pertaining to inoculums development( change control,Deviation,OOS)Equipments/Instruments: • Recording the equipment and instrument logs in the microbiology laboratory.• Maintenance, calibration.• Validation / Requalification of equipment (Autoclave, Incubator shaker etc.) Area Requalification • Protocol • Report• Performance of requalification for lab areaHandling of ERPIdentification of Microbial Isolates

Project 1:- Trials to enhance specific activity of recombinant protein from Pichia pastoris.Project 2:- Trials to enhance solubility and stability of recombinant protein from Pichia pastoris.Technique( Hand on Experience):- Handling of Pilot plant fermenter. Spectrophotometric enzyme assay. SDS-Page. Tricine SDS-Page Protein estimation – Lowry’s method Sample analysis by HPLC Protein Digestion using Kjeldahl method. Inoculum Development Estimation of nitrogen, phosphate and reducing sugar using Skalar.Contribution:-1. Determination of consistency & accuracy of specific activity following each trial.2. Determination of consistency & accuracy of purity and stability following each trial.