Ujwala Singh

Validation Documentation Executive-Pharmaceutical Water Systems at Praj HiPurity Systems
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Contact Information
us****@****om
(386) 825-5501
Location
Mumbai, Maharashtra, India, IN
Languages
  • English -

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5.0

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Ruchi Trivedi

Ujwala managed most of the documentation for projects that I worked on at Neela India Pvt. Ltd. She was very knowledgeable about the processes, which reflected in her documentation. She also has a keen eye for detail, and works toward perfecting her work. She has always tried to complete documentation packets before time, and communicates well with customers/others in the team. She would make a great addition to any team.

Raman Singh

"I know Ujwala now for more than 6 years. We got opportunity to work together in Nilsan-Nishotech---- Ujwala is very good documentation & quality professional.

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Experience

    • India
    • Machinery Manufacturing
    • 200 - 300 Employee
    • Validation Documentation Executive-Pharmaceutical Water Systems
      • Nov 2016 - Present

    • India
    • Industrial Machinery Manufacturing
    • 100 - 200 Employee
    • Validation Documentation Executive-Pharmaceutical Water Systems
      • Feb 2010 - Feb 2015

       Interaction with departments namely, Projects, Design, Commissioning, QA/QC, Sales & Purchase, for execution of project assigned.  Involved in troubleshooting activities at the client end.  Involved in kickoff meetings, designing of the project systems, product development w.r.t. quality, technical & commercial aspects.  Quality check of system components w.r.t. certificates, SOP’s & all related documents.  Involved in team building activities by interacting with departments through meetings, trainings, event managing, etc.  Preparation of Validation Documents (DQ, IQ & OQ), with concern of GMP and as per clients requirements, to comply FDA audits.  Preparation of FAT Protocols, SOP’s & Conducting FAT, IQ along with customer.  Member of ISO committee Strength:  Strong ability to work with Project Management Company, performing multitasking activities, executing the assigned work within the set targets, strong team building ability. Optimistic approach to prospective challenging jobs. Achievements:  Successfully completed training on ISO certification & internal auditor training along with certification & appreciation from organization.  Accumulating Knowledge of guidelines like cGMP, WHO, FDA, ICH GCP, GLP, ISPE, ASME, BPE.  Accumulating Knowledge of validation of equipments like autoclave, tunnel, area validation, etc. Show less

    • Documentation Executive
      • Oct 2008 - Feb 2010

      Preparation of Validation Documents (DQ, IQ & OQ) as per clients requirements to comply FDA audits. Preparation of FAT Protocol & Conducting FAT along with customer; Completion of given set of work within the time frame even in bulk amount. Preparation of Validation Documents (DQ, IQ & OQ) as per clients requirements to comply FDA audits. Preparation of FAT Protocol & Conducting FAT along with customer; Completion of given set of work within the time frame even in bulk amount.

    • Quality Control Officer
      • Nov 2005 - Nov 2007

      Screening of organisms to obtain best suitable products & Maintenance of stock cultures. Improvement in quality of existing products Cost effective studies, Enzyme Assays Implementation of R&D Seed vessel inoculation & transfer to large scale fermenters Controlling & Maintaining critical parameters & Sterility testing Down stream processing Maintaining proper record of each batch Documentation at each step of R&D, Process control, formulation, etc Screening of organisms to obtain best suitable products & Maintenance of stock cultures. Improvement in quality of existing products Cost effective studies, Enzyme Assays Implementation of R&D Seed vessel inoculation & transfer to large scale fermenters Controlling & Maintaining critical parameters & Sterility testing Down stream processing Maintaining proper record of each batch Documentation at each step of R&D, Process control, formulation, etc

Education

  • HAFFKINE INSTITUTE FOR TRAINING, RESEARCH & TESTING, MUMBAI.
    POST GRADUATE DIPLOMA IN CLINICAL RESEARCH MANAGEMENT & REGULATORY AFFAIRS
    2013 - 2014
  • North Maharashtra University
    M.SC Microbiology, Microbiology
    2000 - 2005
  • Transdoc
    Medical Transcription

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