Himanshu Sharma

HIMANSHU SHARMA Meerut, INDIA- - To work for an organization which gives me ample opportunity to explore and showcase my capabilities, skills and in turn whatever I do, I ensure that I do it in the best possible, effective and an ethical manner. Willing to relocate: Anywhere Skills Proficient in pharmaceutical applications/software: PAS-X, SAP, GQCLIMS, BIO-DISCOVERANT, ORACLE ERP, MATLAB, PRISM-GraphPad ARGUS V8, MedDRA coding, Medical writing, Clinical trial processes, c-GMP, c-GCP/c-GLP, BMR, JDE, SHE. Work Experience Bio-Processing Engineer AstraZeneca | Frederick | Maryland, December 2018 – present Implementation of upstream / downstream / central services processing equipment according to established SOPs. This equipment includes but is not limited to bioreactors (Harvesting virus, cell culture), Buffer/media preparation, chromatography skids (Column packaging), Ultrafiltration/Diafiltration skids, autoclaves, washers, and product hold tanks. Recipe via MPR and EBR driven CIP/SIP of tanks and transfer lines. Installation of bio-filters, single use filters and integrity testing of filters. pH/conductivity meters calibration and routine checks, spectrophotometer (SoloVPE), BOM set-up. Sterile connections/disconnections for product transfer from tanks to allegro bag, Allegro bag/cart/tote set-up, Mag-mixers Inventory management (WIP, BOM), Enterprise Asset Management using ORACLE ERP. Participated in internal audits and FDA audits. Post-audit CAPA implementation. Chemistry Lecturer Lilongwe Private school |Malawi, August 2014 to November 2018 Pharmacovigilance Associate WIPRO | New Delhi, January 2010 to July 2014 To perform Individual Case Safety Report (ICSR) and to close processed ICSRs on Oracle Argus Safety database. Database entry/case processing of ADR and SAE in the internal safety database (Argus ver.8.0) within various tabs (i.e. General, patient, product and events tab). Clinical trial cases MedDRA coding and structured abstract/narrative writing, Seriousness, expectedness and causality assessment in Argus. In-depth knowledge and understanding of clinical trial processes and international regulatory requirements (US-FDA, EUDRAvigilance). Formulation Scientist MENTHOLATUM | Scotland, October September 2006 to December 2009 Manufacturing of topical creams, emulsions, gels and ointments as per SOP under cGMP and UKMHRA. Maintenance of batch records, JDE’s, requisition records and SHE records. Update all document as per UKMHRA standards & c-GMP, c-GLP/c-GCP. Calibration of equipment used in formulation (i.e. mixers, homogenizers, filters). Worked as process engineer for new product R&D, process development, process scale-up and technology transfer. Production Pharmacist Wings Pharmaceuticals | Delhi, Delhi January 2003 to July 2005 Worked in the In Process Quality Control (IPQC) under WHO- cGMP/c-GCP guidelines for the testing of pharmaceuticals under production, taking samples from the running machines and documenting the results. Prepared SOPs of batch production of tablets, capsules, ointments, syrups. Also supervised the other departments of Pharmaceutical production, such as Granulation section, packaging. Education Master's in Immunopharmacology UNIVERSITY OF STRATHCLYDE - Glasgow, SCOTLAND August 2005 to September 2006 Bachelor's in PHARMACY S. B. S (P.G) I. B. M. S - Dehradun, Uttarakhand August 1998 to July 2002 Assessments Written Communication — Proficient Jan 2019 View my full results at: https://share.indeedassessments.com/share_assignment/673mv40o6anljgvn Problem Solving — Familiar Jan 2019 View my full results at: https://share.indeedassessments.com/share_assignment/9yy3duzz7-nz8jqq Organizational Skills — Proficient Jan 2019 View my full results at: https://share.indeedassessments.com/share_assignment/ku6hscfuczitznyl Indeed Assessments provides skills tests that are not indicative of a license or certification, or continued development in any professional field.