Roshan Dilip Patil
Senior GxP IT Project Management Specialist I PMP®I CISA I PMI-ACP I CSM®I Ex - EY I Helping LifeScience clients Driving Regulatory Compliance and Risk Management.
- Role
- Senior Gxp IT Project Management Specialist at LTIMindtree
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Roshan Dilip Patil
Experienced Quality Engineering Specialist with expertise in Computerized Systems…
Experience
Senior Gxp IT Project Management Specialist
Sep 2022 — Present · Mumbai, IN
Managed validation projects using CSV SDLC and PMI methodologies, ensuring adherence to timelines and quality standards.• Managed project budgets and resources effectively, overseeing multiple project teams to achieve project goals and deliverables within set timelines and financial constraints.• Developed and implemented validation approaches ensuring compliance with GCP/GLP/GMP requirements aligned with company CSV policy.• Conducted software and vendor risk assessments to maintain data integrity, enhancing overall compliance and operational efficiency.• Leveraged vendor offerings to optimize testing requirements for SaaS systems, achieving significant cost and time savings.• Created comprehensive project plans by fostering cross-functional relationships with IT, QA, Procurement, ELT, vendors, and consultants.• Executed quality functions including CAPA, change control, and deviation management, ensuring robust compliance and operational effectiveness.• Collaborated within project teams, emphasizing planning, monitoring, and review of validation and quality deliverables to meet SOPs and regulatory requirements.
Education
Pethe High School
High School, Science
2000 — 2003
Yash Institute of pharmacy
Master Of Pharmacy, Pharmaceutical Analysis
2010 — 2012
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