Pranitha C Pmp, Cqa, Csm, Astqb Email & Phone Number

Boston, MA, US

Acton, Massachusetts, US

San Diego, CA, US

New Brunswick, NJ, US

-Lead the activities related to validation effort for SaaS applications ensuring compliance to internal procedures, 21 CFR Part 11, GxP regulations for various modules of Medidata.-Create, review Compliance Analysis, Compliance Plan, Architecture Design, Test Plan, Test Scripts, and Compliance Reports.-Support risk-based validation, advise on regulatory.

Tokyo, JP

• Author User Requirements including developing work-flows, task management through the system between different groups, assignment of roles based on user-access criteria, compliance to 21 CFR Part 11, MHRA, EU.
• Lead the project team for hosting vendor supported application, providing guidance in terms of SDLC deliverables needed for a GxP regulated system.
• Develop UAT Test Plan, Electronic Records and Electronic Signatures Compliance (ER/ES) Assessment Form, Data Migration Plan, Migration Summary Report, UAT Test Closure Memo, Traceability Matrix, Master Validation Plan.
• Coordinate with off-shore testing teams in developing UAT scripts, acting as a liaison between off-shore teams and end-users.
• Assist in writing Test Strategies, UAT scripts, test data set-up and UAT execution by end-users.
• Review and approval of UAT test scripts, migration qualification scripts, change requests, project plan and other key deliverables.

Tokyo, JP

• Involved in updating the Testing Methodology for the QA department and generating various documents to provide uniformity in the execution and reporting of tests.
• Ensured validation documentation to be compliant with cGXP standards.
• Performed GAP analysis and remediation plans for non-conforming applications with regards to 21 CFR Part 11.
• Developed risk analysis strategies and their mitigation with keen insight on to business requirements and regulatory guidelines.
• Ensured the collection, compiling, reporting and dissemination of key quality metrics is completed within the required time frame.
• Strong analytical problem solving skills and statistical application knowledge in areas such as sampling techniques, regression, and reliability.

North Chicago, Illinois, US

• Worked on Foundation SAP implementation project as a Quality Engineer. Involved in maintaining regulatory compliance and validating testing methods for procurement of raw materials, work flow management of vendors.
• Reviewed and Approved Integration, Functional and System Testing scripts. Developed, reviewed and approved end to end scenarios like OTC, PO Changes, Demand Planning, forecasting and inventory planning, MES interfaces.
• Analyze validation test data to determine whether systems or processes have met validation criteria and to identify root causes of production problems. Prepare validation and performance qualification protocols for new.
• Good experience in using tools such as HPQC (v11.0), Solution Manager (SAP SolMan v.7.0 and 7.1) that are used to maintain data and work flow. In depth knowledge of SAP workflow, QM, SCM, MFG, OTC, RTR process areas.
• Responsible for oversight and approval of reports documentation and testing activities of Quality Systems, in effort to meet the goals.
• Developed VB codes and SQL queries for Excel and SQL Reporting for Quality Audit purposes. Proficient in writing SOPs, protocols, drafting and routing certification summaries after thorough analysis of SDLC per FDA.

Macomb, IL, US

• Involved in teaching laboratory course-work for Undergraduate students.
• Created database for test results, analysis of grades.
• Maintained all the records such as student assignments, grades in the database and excel.
• Validated Origin Lab, Chemstation, and various equipment including interfaces with softwares and analyzed results to ensure acceptance criteria.
• Documented test results, defect analysis and created test summary reports.

Hyderabad, AP, IN

• Underwent formal training in the areas of Production, Manufacturing, Quality Control and Quality Assurance.
• Trained in Regulatory aspects of Quality Assurance along with validation procedures adopted for successful compliance and adherence to standards in Pharmaceutical domain.

• Worked as Research Assistant to develop skills in writing SOPs, IQs, OQs, PQs for systems and processes.
• Involved in developing test criteria and test case scenarios for validation of pharmaceutical equipment and their interfaced softwares.

Master Of Science - Ms

Bachelor Of Pharmacy - Bpharm