Sruthi Reddy Email & Phone Number

A versatile and analytical individual with good knowledge on Computer system validation. Good presentation skills and strong ability to quickly establish rapport with people from diverse backgrounds. Worked on validation protocols, including Installation Qualification Reports (IQR), Operational Qualification (OQ), and Performance Qualification (PQ) for STARLIMS.Prepared validation documentation including Validation Plans, Functional Requirement Specifications (FRS), and Traceability Matrix, Configuration Specification document. Validation Reports etc., Contributed to the validation of LIMS ensuring compliance with regulatory requirements such as 21 CFR Part 11 and GAMP 5. Have good understanding in SDLC and Testing life cycle such as Validation protocol, Test case Preparation Test case execution, Defect reporting and Tracking. Fostered collaborative relationships with vendors and external consultants, leveraging collective expertise to swiftly resolve validation challenges and optimize system efficiency. Has good understanding of Pharmaceutical and Biologics process workflows. Conducted Functional Risk assessments and gap analyses to identify potential compliance issues and implemented corrective actions to ensure system integrity. Involved in all the phases of Testing (STLC), Maintenance and Business Support Testing and Expertise in Functional Testing. Reviewed and updated validation protocols, test scripts, and Standard Operating Procedures (SOPs) to reflect changes in system configurations and regulatory requirements

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  Jntu. Hyderabad

  Pharmacy