Manjushri Gawhane
Pune
Summary
Detail-orientated validation professional with 11+ years of experience in Life Sciences and Health Care domain with expertise in Computer System Validation and Project Management. My key achievements include leading significant validation projects that enhanced security and efficiency in pharmaceutical operations and executing complex validation test plans for major clients. Seeking an IT Professional Validation opportunity, where I bring my computer system validation and project management skills to support organizations varied validation needs.
Overview
16
16
years of professional experience
Work History
Senior Validation Consultant
Instem India Pvt Ltd
Pune
08.2021 - Current
- Orchestrated validation projects, including planning, scheduling, and resource management, along with providing validation deliverables that facilitated comprehensive risk assessment and reporting.
- Design and execution of validation activities, and collaborate with the client for planning, requirement gathering, and compliance documentation.
- Collaborated closely with cross-functional teams, including product development and SaaS cloud implementation, to gather validation environment details, facilitate communication, and ensure alignment on quality objectives throughout the validation project.
- Successfully led the audits and achieved zero compliance issues by establishing comprehensive data integrity protocols for a preclinical trial data management system.
- Review and approval of validation deliverables, client-facing materials, and distribution.
- Directed and led preclinical study setup and system reports from a validation standpoint to enhance the overall quality of validation deliverables.
- Initiated and maintained the validation processes, work instructions, and validation templates.
- Fostering strong teamwork and providing mentorship to enhance domain skills for continuous improvement.
Validation Consultant
Q-force Pharma Consulting LLP/Cognizant
Pune
11.2020 - 08.2021
- Led the validation test activities for a leading pharmaceutical company by implementing best practices and thorough documentation, enhancing compliance with regulatory standards.
- Assessed the risk and advised on the mitigation activities for the system changes.
- Developed and executed comprehensive test scripts required for Operational Qualification (OQ) and Performance Qualification (PQ) in health, safety, and environment (HSE), along with defect tracking, and CAPA management.
Application Tester and Subject Matter Expert
Bio-Analytical Technologies (India) Pvt. Ltd.
Pune
06.2011 - 02.2019
- Collaborate with the software development team to provide domain inputs and test the software with respect to Acceptance Criteria, Regression Testing, and Regulatory requirements.
- Successfully led the chromatography testing efforts with a UK-based client, ensuring the timely delivery and software release.
- Performed a gap analysis against 21 CFR Part 11 and Section 508 of the Rehabilitation Act, and designed the validation approach.
- Designed and executed test cases for chromatography, device drivers that are supported by the Chromatography Data System and Clinical Trial Management System (CTMS), ensuring quality objectives throughout the software life cycle management.
- Achieved hands-on expertise in chromatography and mass spectrometry instruments to efficiently test software functionalities and other integrated laboratory equipment.
Chemist
Deepak Nitrite Ltd.
Pune
12.2009 - 03.2010
- Conduct the preliminary analysis of effluents generated during production, and perform effluent bio-degradation studies.
- Successfully conducted the quality assurance analytical tests for the various samples on instruments like High Performance Liquid Chromatography, Gas Chromatography, and UV-Spectrophotometer.
Microbiologist
Accurate Analytical Laboratory
Pune
11.2008 - 10.2009
- Designed microbial assays for food, water, Ayurvedic medicines, and soil samples, ensuring the client's requirements.
- Microbial assay reporting ensures alignment with the quality management system.
Education
Master of Sciences - Microbiology
University of Pune
07-2008
Bachelor of Sciences - Microbiology
University of Pune
06-2006
Skills
- Computerized System Validation
- 21 CFR part 11
- GxP
- GAMP
- Annex 11
- Data Integrity
- Section 508 of the Rehabilitation Act
- HPALM
- Azure DevOps
- JIRA
- Document Management System
- SharePoint
- Risk Assessment
Accomplishments
- Awarded with Best Poster Award at the 6th Nutra India Summit 2011, for Prebiotic potential of some Mangifera indica varieties.
- Appreciated with Kudos Awards in recognition of consistent high performance and efficient team management.
Timeline
Senior Validation Consultant
Instem India Pvt Ltd
08.2021 - Current
Validation Consultant
Q-force Pharma Consulting LLP/Cognizant
11.2020 - 08.2021
Application Tester and Subject Matter Expert
Bio-Analytical Technologies (India) Pvt. Ltd.
06.2011 - 02.2019
Chemist
Deepak Nitrite Ltd.
12.2009 - 03.2010
Microbiologist
Accurate Analytical Laboratory
11.2008 - 10.2009
Master of Sciences - Microbiology
University of Pune
Bachelor of Sciences - Microbiology
University of Pune
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