Srinagesh Kodancha G

Seasoned validation expert in Life Science IT with extensive experience in implementing and validating multiple SAP S4 HANA systems for global rollouts. Over 15 years of specialized expertise in the pharmaceutical and life sciences domain, particularly in Computer System Validation (CSV), Computer System Assurance (CSA), and Quality Assurance. Holds a postgraduate degree in Pharmacy (M.Pharm) complemented by certifications in Intellectual Property Rights from IISc Bangalore and as a Certified Business Analyst (Foundation). Demonstrates a strong commitment to ensuring compliance and quality within complex regulatory environments.

• Managed Team of validation experts up to size 13 +
• Support/Involved in RFPs, Orals for new opportunities, including establishing the framework for RfP estimation
• Authored Master Validation Plan for larger implementation programs
• Defining Program Level Risk based Qualification/Validation strategy for cloud infrastructure & SAP S4 HANA Systems
• Authored/Managed of Overall Validation/ Test Plans & reports for release/applications
• Management of review and approval of SDLC qualification deliverables like various user/design specifications, scripts & traceability matrix
• Periodic Internal Audit on Project Quality Health
• Defining QMS/SDLC process by authoring / reviewing of supporting SOPs / WIs to support Quality Management System
• Defining Training requirement for account / program. Periodic Trainings to Project Team Members
• SME role to assist the team to understand the regulatory requirements in implementing applications for GxP use
• Bridge between IT Consultants and Quality Groups
• Equipment, Facility & Utility Qualification for large biotech & pharma (solid & parenteral dosage) manufacturing unit, including PLC verification
• Contribute as individual contributor when required

• Date of Birth: 02-Jul-1983
• Nationality: Indian
• Marital Status: Married