Sayali Deshpande

About Sayali Deshpande

I have graduated in Biotechnology engineering with areas of interest in bioprocecss and bioseparation techniques. Currently pursuing MBA from BITS Pilani. I have experience in Mammelian Cell culture techniques and installation of Single use bioreactor. QMS (Trackwise), DMS, Designing and execution of werum PASX in Development/ Validation/ Production environment.Also I\'ve knowledge of clinical research, ICH GCP guidelines,#GxP, 21 CFR Part

Experience

1. Executive

   Reliance Life Sciences Pvt. Ltd

   Nov 2021 — Present · Mumbai, IN

   QMS (Trackwise) for Deviations and Change controlDMS (PharmaRedy) for BMR, SOP creation and revisionsPAS X development/ Validation/Production environment including planning, implementation, operation, and continuous improvement. Develop and implement strategies and processes aligned with regulatory compliance.Logically break the recipes/manufacturing process to create process flow diagrams for pharmaceutical product based on paper batch manufacturing records or source documents.Design and creation of complex MBR for Weighing & Dispensing, Manufacturing processesExperience on Werum PAS-X System Administration, Equipment Management, Material Flow, Weigh & Dispense, EBR, MBR & Master Data Designing and developing State Diagrams in MESDetermining updates for Master Data, State Diagrams, Equipment managementExperience on SAP-MES interface, LIMS integrations.Integrate Werum PAS X with ERP/SAP, SCADA and other automation systems using standard interface components of MBR design.Hands on Experience in Werum PAS-X Specification, Execution, Compliance & Performance Module.Knowledge of #GxP,#GAMP, 21 CFR Part Batch planning of production batches, supervise media and reagent preparation, sterile filtration, sterile transfer of culture, batch monitoring, biochemical analysis of daily cell culture samples, decontamination and material movement as per cGMP procedure.Handling single use wave based and stirrer tank bioreactor (20L, 200L and scale), Single use mixer and Depth filtration system for monoclonal antibody production (Products- Rituximab, Trastuzumab, Bevacizumab, Tenecteplase, Eternercept, Denosumab).• Work on SAP Batch posting, MRS creation for inventory management and production planning.•QMS and DMS, BMR revisions, Investigation report preparation, Change control and deviations

Education

• Birla Institute of Technology and Science, Pilani

  Master of Business Administration - MBA

  2024 — 2026

• KIT's College of Engineering (Autonomous), Kolhapur

  Bachelor of Engineering - BE

  2016 — 2020