Venkat Kakarlapudi

Overall 12+ years of professional experience in Computer System Validation, as a Project Quality Manager, Software Quality Assurance and Clinical Trials Applications Testing in Healthcare/Life Sciences Domain.

➢ As an Quality& Compliance consultant is responsible to ensure compliance to Computer System Validation principles, practices.

➢ Experience in having validation strategy for huge transformation programs/projects with complexities around implementation and integration relating to Patient Safety, Product Quality and Data Integrity, developing and executing validation, qualification and migration strategies for IT systems in adherence to applicable global regulatory requirements, company policies and standard operating procedures.

➢ Familiar with SAP modules like Materials Management, Quality Management, Production Planning, Sales & Distribution.

➢ Well experienced in GxP and Non-GxP related Validation and Qualification strategies.

➢ Experience working within the guidelines provided by regulatory agencies such as FDA, MHRA, etc. on one or more of the following areas: CFR Title 21 (parts 11, 210, and 211), Annex 11, GAMP, V-Model, CAPA, cGxP (GMP, GLP, GCP, GVP, etc.), ERES regulations and Audit Trail functionality.

➢ Experienced in SDLC (Waterfall or Agile methodologies) and responsible for tracking and monitoring validation process to ensure timely and cost-effective delivery of the system to the business users.

➢ Good understanding on Change Management and Change Control Procedures, Deviation Handling, and CAPA management.

➢ Authoring and Review of CSV protocols (Validation Plan, IQ, OQ, PQ, Traceability Matrix and Change Request/Validation Summary Report) as per the RACI matrix of Waterfall/Agile SOP.

➢ Liaised with cross-functional teams to ensure alignment on validation approach and deliverables and escalate critical issues via appropriate channels.

➢ Experienced in interacting and guiding functional and technical team members on Computer Validation principles practices.

➢ Involved in migration of clinical studies in to Operational DB from legacy systems.

➢ Experienced in Identify and log issues found during validation execution, perform rootcause analysis to define corrective and preventive measures to be taken.

➢ Having in-depth understanding of clinical trial phases of drug development processes from discovery through development and post-marketing.

➢ Having excellent Knowledge of validation life cycle (V-Model) and Good Documentation Practices. Experienced in authoring, reviewing and executing CSV documentation. ➢ Involved in working with tools such as SAP, HP ALM, ServiceNow. Experience in cloudbased applications.

➢ Worked for Clinical Trials project “Interactive Response Technology” in which we come across SCM (Supply Chain Management) module where I have experience on Drug Supply Chain Management Process.

➢ Done more projects in Clinical Trial Validations and Wellness Applications out of which worked on Oracle Products “InForm” system validation, InForm Integration projects for different Clients and Oracle Product “Interactive Response Technology (IRT)”, IVRS [Interactive Voice Response System], LNMT [Lab Normals Management Tool] , Oracle Clinical, Oracle Argus.

➢ Actively participating in all Scrum ceremonies (Daily stand up, Sprint planning, Grooming, Sprint retrospective and Sprint reviews) in Agile framework.

➢ Excellent verbal, written and presentation skills. Strong analytical and problemsolving skills.

➢ Self-motivated, work well in a team structure or independently and have a strong work ethic.