Koteswara Rao K

• - Spearheaded CSV activities for multiple GxP and non-GxP systems across the system lifecycle.
• - Developed and maintained validation deliverables: URS, FRS, Risk Assessments, IQ/OQ/PQ, RTM, VP, and VSR.
• - Conducted 21 CFR Part 11 assessments, remediation, and compliance verification for lab/manufacturing systems.
• - Led SAP S/4HANA cloud migration (On-prem to AWS) including risk evaluation, vendor qualification, and data migration testing.
• - Executed test scripts, managed defects in HP ALM, and performed system configuration reviews.
• - Supported change control, backup & restore, data archival, CAPA analysis, and system decommissioning.
• - Managed validation lifecycle documentation in Veeva Vault and participated in periodic reviews and compliance audits.
• Domain: GxP Systems | Environment: Cloud (AWS), SAP, GAMP 5
• Key Project: SAP Cloud Migration – CSV Oversight
• - Developed validation documentation (URS, VP, CC, QRA, IQ, OPQ) aligned with GAMP 5 guidelines.
• - Coordinated cross-functional efforts with SAP Basis and AWS infrastructure teams.

• - Validated enterprise platforms including LabWare LIMS and CTMS under CSV protocols.
• - Performed gap assessments, risk analysis, and generated VMPs and validation documentation (URS, FS, VP, IQ/OQ/PQ).
• - Supported revalidation activities post-system upgrades and enforced alignment with internal SOPs.
• - Acted as Validation Lead for site-level and global IT compliance projects.
• Domain: Pharma IT Systems

Developed and maintained Validation Master Plans, Risk Assessments, and protocols per GAMP 5 standards.

• Executed validation lifecycle activities for GxP systems across Manufacturing, QC, and Clinical applications.
• Managed Change Control, Deviation Handling, and CAPA processes for validated systems.
• Conducted vendor qualification assessments and evaluated supplier validation deliverables.
• Analyzed customer requirements to ensure compliance with regulatory standards.
• Created test scripts and executed tests according to the validation plan.