Kapil S Hora, Ms Email and Phone Number
Kapil S Hora, Ms work email
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Kapil S Hora, Ms personal email
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Accomplished engineer with 15+ years of experience in the pharmaceutical industry, specializing in driving process improvements, asset lifecycle management, and SAP plant maintenance. Proven expertise in leading cross-functional teams and overseeing quality systems to ensure regulatory compliance and GMP standards. Adept at solving complex challenges and optimizing operations to deliver impactful results.
Nutcracker Therapeutics
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Quality Systems ManagerNutcracker Therapeutics Jul 2023 - PresentEmeryville, California, Us• Acted as primary QA point of contact for Facilities Services, Supply Chain, Manufacturing, and Device Development at Nutcracker Therapeutics.• Led oversight of complex SOPs, ensuring GMP readiness and compliance with critical systems like CMMS and ERP.• Managed multiple change records to maintain compliance and operational integrity, serving as SME for Maintenance and Facilities operations.
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Maintenance Systems ManagerNutcracker Therapeutics Jun 2021 - Jul 2023Emeryville, California, Us• Led the design, build, and qualification of GMP facility and supporting procedures at Nutcracker Therapeutics.• Implemented Nuvolo CMMS and REES EMS systems, contributing to efficient maintenance processes.• Provided expertise in GMP compliance, regulatory requirements, and change control for facilities maintenance.
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Sr. Compliance Specialist, Tech OpsSangamo Therapeutics, Inc. May 2020 - Jun 2021Brisbane, California, Us• Led the revamping of new Hire Training curriculum in Compliance Wire LMS, improving training assignments timeline by 90%.• Managed weekly CMMS and cross-functional staff meetings, ensuring timely execution of action items for facility operations.• Streamlined 12 QC monthly cleaning work orders to 3, focusing on continuous improvement and efficiency. -
Sr. Project Engineer (Global Quality)Biomarin Pharmaceutical Inc. Jan 2020 - May 2020San Rafael, Ca, Us• Developed and implemented a new on-boarding process in Compliance Wire LMS, increasing efficiency by 50%• Managed workflow from mapping processes to testing and implementation for QC and QA teams• Automated manual tasks, created smart rules, and streamlined processes for Global Quality Ops at BioMarin Pharmaceutical Inc. -
Sr. Project Engineer (Ehss)Biomarin Pharmaceutical Inc. May 2019 - Jan 2020San Rafael, Ca, Us• Developed biotechnology training materials ensuring compliance with NIH guidelines.• Reviewed process flow diagrams for drug substances, recommending safety measures.• Provided recommendations for wastewater discharge systems and manufacturing infrastructure.• Represented as EHSS engineer for lab and warehouse projects at BioMarin Pharmaceutical Inc.
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Sr. Project/Automation EngineerGenentech Apr 2018 - Apr 2019South San Francisco, California, Us• Updated detailed design document for MES applications resulting in 10% testing duration improvement.• Managed discrepancies in Trackwise for automation during testing phases.• Provided technical support on discrepancy management system for product recipe issues. -
Sr. Project/Process EngineerGenentech Sep 2016 - Mar 2018South San Francisco, California, Us• Conducted process failure mode and effect analysis (FMEA) for Bottle Dispensing Unit (BDU) in CCP2, ensuring optimal performance.• Managed procurement of critical spares for BDU from vendors, enhancing equipment reliability.• Updated project documentation and Bill of Material (BOM) structure in SAP database for streamlined operations.
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Project ManagerGenentech May 2014 - Aug 2016South San Francisco, California, Us• Managed supply chain master data entry and integrity at Genentech Vacaville, ensuring compliance with FDA regulations.• Developed 200+ receipt inspection records for process-contacting parts, including FDA Title 21 Part 11 and USP Class VI certifications.• Created an Approved Supplier List (ASL) and conducted online supplier audits to verify ISO 9001 compliance.
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Project/Process EngineerGenentech May 2012 - Apr 2014South San Francisco, California, Us• Conducted technical analysis on micro-processor instruments and recommended improvements.• Reviewed and optimized over 100 instrument configuration templates using various platforms.• Developed a new layout to track progress of 1000+ application-based instrument notifications in SAP software.
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Project EngineerGenentech Jun 2011 - Apr 2012South San Francisco, California, Us• Streamlined business processes for capital and expense projects, resulting in a 30% cost savings.• Developed resource tracking and cost estimator tools for efficient project management.• Created asset grouping maintenance strategies and documented calibration requirements for 200 GMP assets.
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Maintenance Data Systems EngineerGenentech Jun 2009 - May 2011South San Francisco, California, Us• Organized technical information for over 2000 components and materials to support GMP preventive maintenance and repair activities.• Generated tracking and trend reports for supply chain and inventory management through data analysis.• Conducted internal audits of warehouse facility, reviewed compliance with storage requirements, and provided improvement recommendations.
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Instrument Engineer - InternGenentech Jun 2008 - May 2009South San Francisco, California, Us• Developed and implemented a business process for assigning equipment numbers, resulting in documentation of 550 instrument spare parts in 6 months.• Organized and optimized 250+ instruments using 5S/Lean-manufacturing techniques in Calibration Lab, Standards Room, and Training Labs.• Reviewed and aligned Instrument Standards for 2000 instruments across all Genentech plants with Standard Record 955 and SAP.
Kapil S Hora, Ms Skills
Kapil S Hora, Ms Education Details
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California State University - East BayEngineering Management -
University Of MumbaiChemical Engineering
Frequently Asked Questions about Kapil S Hora, Ms
What company does Kapil S Hora, Ms work for?
Kapil S Hora, Ms works for Nutcracker Therapeutics
What is Kapil S Hora, Ms's role at the current company?
Kapil S Hora, Ms's current role is Asset life-cycle I Compliance I Quality Systems I Maintenance Systems I Program/Project Management I VSM I 5S.
What is Kapil S Hora, Ms's email address?
Kapil S Hora, Ms's email address is ka****@****ail.com
What schools did Kapil S Hora, Ms attend?
Kapil S Hora, Ms attended California State University - East Bay, University Of Mumbai.
What are some of Kapil S Hora, Ms's interests?
Kapil S Hora, Ms has interest in Social Services, Children, Environment, Education, Science And Technology, Animal Welfare, Health.
What skills is Kapil S Hora, Ms known for?
Kapil S Hora, Ms has skills like Engineering, Gmp, Manufacturing, Sap, Process Improvement, Chemical Engineering, Process Engineering, Data Analysis, Cross Functional Team Leadership, Quality Assurance, Project Management, Biotechnology.
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