Ujwala Singh
Validation Documentation Executive-Pharmaceutical Water Systems at Praj HiPurity Systems- Claim this Profile
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Bio
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.
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.
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.
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.
Experience
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Praj HiPurity Systems
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India
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Machinery Manufacturing
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200 - 300 Employee
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Validation Documentation Executive-Pharmaceutical Water Systems
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Nov 2016 - Present
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Nilsan Nishotech Systems Pvt Ltd
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India
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Industrial Machinery Manufacturing
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100 - 200 Employee
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Validation Documentation Executive-Pharmaceutical Water Systems
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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
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Documentation Executive
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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.
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Quality Control Officer
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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
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Education
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HAFFKINE INSTITUTE FOR TRAINING, RESEARCH & TESTING, MUMBAI.
POST GRADUATE DIPLOMA IN CLINICAL RESEARCH MANAGEMENT & REGULATORY AFFAIRS -
North Maharashtra University
M.SC Microbiology, Microbiology -
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