An avid manufacturing professional with 8+ years of experience in Manufacturing, C&Q and QMS.I completed M.Sc. Life Science from National Institutes of Technology Rourkela, Odisha. I worked with Biocon Biologics Ltd Bangalore, as an Executive in protein purification (Down Stream) from 1 Feb 2016 to 28 June 2019.I worked with Athem bioscience as senior Executive in protein purification (Down Stream) from 1 July 2019 to 18may 2022.Currently working with Intas biopharmaceutical as senior Executive in down stream (Gcsf) From 23 may 2022 to till date.. Audit: USFDA, EMA & internal. Handling Chromatography: RP-HPLC, HIC, Ion Exchange (cation & Anion) Chromatography, Size exclusion chromatography(Akta Process and Akta Pilot, Unicorn 7.3, 7.0.2). BPG Column Packing & UnpackingTangential Flow Filtration: UFCIP & SIP. Participated for C&Q of Clean Utilities and Process equipment (Biologics)Responsible for preparation and co-ordination of Quality Risk Assessments (FMEA) for Equipment, based on URS.Responsible for planning, execution & co-ordination of C&Q program for Downstream Suite. (URS to PV).Preparation and execution of in-house qualification protocols and Test scripts.Review and management of qualification dossiers/turnover packages. (URS to OQ)Manufacturing professional (Team Leader) in DSP and Handling of various Batches (Familiarization batch, Development batches, PV batches etc).Preparation, implementation, review and execution of Standard Operating Procedure (SOP) and Batch Manufacturing Report (BMR).Responsible for Cleaning Validation Studies for downstream equipment. GMP & GDP. participated in SAP Implementation. In-Process checking and handling on various intermediate stages.CentrifugeCrystallizerLyophilizerAutoclavePart WasherNow I am looking my carrier in...Quality Assurance, QMS, OR Manufacturing.. In the field of Biological System.