Srikanth Kanameni

Operations Associate

San Francisco, California, United States12 yrs 10 mos experience

Most Likely To SwitchHighly Stable

Key Highlights

Over 10 years in Quality Assurance
Expert in Validation and Compliance
Strong Biomedical Science background

Stackforce AI infers this person is a Quality Assurance expert in the Healthcare industry with a focus on validation and compliance.

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Skills

Core Skills

ValidationProject Management

Other Skills

Data AnalysisDeviation ManagementDocumentationDocumentumGMPHP Application Lifecycle ManagementISO 13485Interpersonal SkillsLeadershipMicrosoft OfficePL/SQLProgrammingProject PlanningPublic SpeakingPython (Programming Language)

About

Experienced Quality Assurance professional with a demonstrated history of working in pharmaceutical and medical devices. More than 10 years of experience performing projects to support Quality Management Systems. Skilled in Equipment & Utility Qualification, Validation, Cleaning Validation, GMP, Pharmaceutical Industry, Good Manufacturing Practice (GMP), ISO 13485, Good Laboratory Practice (GLP), 21 CFR Part 820, Standard Operating Procedure (SOP) and additional FDA regulations. Strong Biomedical background with MS in Biomedical Science and IT professional experience. I also engage in collaborative professional freelances to hone my skills in a changing world. Collaboration has allowed me to network with some of the finest people & learning from them helped me immensely to grow both professionally and personally.

Experience

12 yrs 10 mos

Total Experience

3 yrs 2 mos

Average Tenure

3 yrs 11 mos

Current Experience

Gilead sciences

2 roles

Validation Specialist

Jun 2022 – Present · 3 yrs 11 mos · San Francisco Bay Area

Good understanding and practical knowledge on LabX system integrated with different applications like pH meter and Balances.
Tested and provided feedback in necessary changes required in various methods developed through LabX system.
Assessed and developed required validation deliverables in collaboration with cross functional team members including user/SME and QA to ensure consistency in validation project execution.
Work with business owners and stakeholders to develop the User Requirements Specification (URS), Functional Requirements Specification (FRS) and Design Specification (DS).

ValidationProject ManagementData Analysis

Validation Engineer

May 2015 – Mar 2021 · 5 yrs 10 mos

Develop test scripts for GxP systems implementation for different phases of testing for e.g., system testing, regression testing, user acceptance testing and performance testing.
Coordinates & executes validation change control and preparation of draft protocols, and reports.
Responsible for authoring validation deliverables such as Validation Plan, Data Migration Plan, Test Plan, Installation Qualification, Operation Qualification, Performance Qualification, Requirement Traceability Matrix, and Test Summary Report.
Responsible for developing and executing on validation plans according to approved procedures, collation of test results, and organizes data packages and maintains all documentation pertaining to validation.
Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements.

ValidationData AnalysisDocumentation

Vineti

Validation Lead

Mar 2021 – Jun 2022 · 1 yr 3 mos · San Francisco Bay Area

Led a small team of testers to test and validate the product.
Provided guidance to clients on assigning proper risk to computer systems.
Provided guidance to clients on how to meet compliance requirements using a risk-based approach.
Develop validation documentation and standard operating procedures for various GxP applications.
Develop test protocols that thoroughly test business requirements.
Provide test execution oversight and assist with deviation recommendations as required.

ValidationProject ManagementRisk Management