
Kothapalli Reddy
• About 7+ years of extensive hands on experience of Computerized System Validation for Life Sciences Applications • Responsible for ensuring... | Hyderabad, Hyderabad, India
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Kothapalli Reddy’s Emails ko****@no****.com
Kothapalli Reddy’s Phone Numbers 1212830****
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Kothapalli Reddy’s Location Hyderabad, Hyderabad, India
Kothapalli Reddy’s Expertise • About 7+ years of extensive hands on experience of Computerized System Validation for Life Sciences Applications • Responsible for ensuring the implementation of regulated systems on Cloud Platform comply with follow Computer System Validation standards in terms of GAMP 5 guidelines, organizations CSV Process with knowledge of FDA 21 CFR regulations, Good Documentation Practices, Good Testing Practices, Change Management Process. • Provide strategy, planning, estimate, recommendations and guidelines for all Computer System Validation Projects. • Interact with business & the clients to understand and gather business requirements; pro-actively propose solutions on CSV projects that will add value to the company. • Good exposure on Life Cycle documentation, Knowledge on preparing Validation Master Plan, Validation Protocols. • Preparation and execution of 21 CFR Part 11, EU annex 11 assessments for QC laboratory systems. • Experience in Testing of PLC, SCADA Software/Hardware. • Test Schedule Preparation, Preparation of Bill of Materials, Customer Approvals, Conducting Factory Acceptance Test, Site Installation/Testing/Commissioning and completing Site Acceptance Test. • Experienced with dealing directly with clients/end-users and liaising with other departments and sub-contractors to ensure projects are completed successfully and on time.
Kothapalli Reddy’s Current Industry Novartis
Kothapalli
Reddy’s Prior Industry
Novartis
|
Aztec Consulting
|
Shantha Biotechnics Limited A Sanofi
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Work Experience

Novartis
Project Quality Management Expert
Sun Aug 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Shantha Biotechnics Limited A Sanofi
Validation Specialist- Csv
Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Aug 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Aztec Consulting
Jr.Automation Engineer
Mon Aug 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Novartis
Project Quality Management Expert
— Present