Himansu Sekhar Dash Email and Phone Number

* Fluent knowledge of concepts of Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (cGMP) guidelines.* Qualification (URS,FAT,SAT,CQ,DQ, IQ, OQ, PQ) of all equipments related to parenteral preparation.(injection)* Qualification of Facility, HVAC system, process Equipment’s, utilities, laboratory equipment’s and visual inspection equipment’s* CSV computerized system validation* process validation* Cleaning validation* Transport Validation (Air and Sea)* Risk assessment* Equipment testing* Compliance management* Procedure development* Information collection and analysis* Process improvement* Communication skills* Team supervision* Teamwork skills* Quality review processes* Adobe Premier PRO Video Editing* ERP(Enterprises Resource planning).* Conducting of training sessions* QMS systems related to validations and qualificationsKnowledge of GMP aspects and regulatory requirements with rich experience of Validation & Qualification of Process Equipment & clean Utilities. Comprehensive knowledge in guidelines of regulatory bodies like USFDA-USA, ANVISA-Brazil, PICS,ISO,EU ,PDA,GAMP & ISPE baselines and CGMP etc.I have exposure/experience as mentioned below. 1. Process side:RODUCTION SHOPFLOOR ACTIVITIES (PLANNING,ERP,BMR,SOP,TS,AUTOCLAVE,WASHING,TUNNEL,FILLING,SEALING ,STATIONARY and PPM DISPENSING)2. Clean utility Side:Clean Utilities (WFI/PW/PS) and gases (O2/N2/CO2), etc.3. Commissioning & qualification (CQV):IQ, OQ preparation & reviews for process equipment’s like Process tank system, Autoclave,TS,Filling , sealing ,Lyophilzer and other critical process & clean utility equipment Commissioning of Process & Utility equipment for Pharmaceutical industry like Filling,sealing,PW,PSG,WFI system, etc., functional Design Specification writing and validation of various process equipment like filling,sealing etc.4.Area validation:HVAC (CS/IQ/OQ/PQ),Airflow visualisation,Temperature mapping,Sound,Lux and Recovery.5.Transport validation:Shipping by sea Shipping by Air 6.Facility Qualification