Pratima Zamre Email & Phone Number | I am a proactive and achievement-oriented professional with nearly 16 years of rich & extensive experience in Computerized System Validation and Quality & Compliance Consulting in Life Science domain. Expertise in preparing documentation like protocols, system qualification documents, validation plan, validation report, GxP assessment and allied activities for the software/applications. Excellence in end-to-end management of validation activities including writing execution and review of validation protocol for GxP regulatory systems. Rich knowledge of Regulatory guidelines of 21 CFR Part 11 of FDA, GAMP 5.0 and Good Documentation Practices. Managed STLC entailing scripting, analyzing & implementing test scripts, test cases, test processes, defect reporting, bug tracking, and report generation of different applications / products. Executed large-scaled & medium-scaled projects using Agile/ Waterfall methodologies. Extensive experience in mapping & understanding client's need & requirements and communicating them and the quality standards to the respective team.

Pratima Zamre

I am a proactive and achievement-oriented professional with nearly 16 years of rich & extensive expe...
Pune, Maharashtra, India

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Pratima Zamre’s Location Pune, Maharashtra, India

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Pratima Zamre’s Prior Industry Novartis | Cognizant | Cognizant Technology Solutions

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Project Quality Specialist

2021-06-01 00:00:00 - 2023-11-01 00:00:00

Manager

2019-10-01 00:00:00 - 2021-06-01 00:00:00

Senior Associate

2013-11-01 00:00:00 - 2019-09-01 00:00:00

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Pratima Zamre is a I am a proactive and achievement-oriented professional with nearly 16 years of rich & extensive experience in Computerized System Validation and Quality & Compliance Consulting in Life Science domain. Expertise in preparing documentation like protocols, system qualification documents, validation plan, validation report, GxP assessment and allied activities for the software/applications. Excellence in end-to-end management of validation activities including writing execution and review of validation protocol for GxP regulatory systems. Rich knowledge of Regulatory guidelines of 21 CFR Part 11 of FDA, GAMP 5.0 and Good Documentation Practices. Managed STLC entailing scripting, analyzing & implementing test scripts, test cases, test processes, defect reporting, bug tracking, and report generation of different applications / products. Executed large-scaled & medium-scaled projects using Agile/ Waterfall methodologies. Extensive experience in mapping & understanding client's need & requirements and communicating them and the quality standards to the respective team.