Srushti Patel Email & Phone Number

New York, New York, US

• Provide support for SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans.
• Perform Gap Assessments and Remediation Plans with an understanding of applying risk management principles.
• Ensure appropriate regulations, such as 21 CFR Part 11, 820 and cGMP regulations, are addressed in validation.
• Provide training to colleagues and contractors on our approach to systems implementation and validation SOP's.
• Assist validation activities of cross functional teams that include technical functions such as Information Systems, Manufacturing and QA Engineering.
• Develop and maintain Validation SOPs, forms, documentation and files.

Monitor GMP operations in Production and to ensure company Processes Comply cGMP.Review and document data of errors and incidents with root cause analysis and corrective actions.Co-ordinating with suppliers of raw materials, work to decrease material lead times and improve supply chain.Work with quality Manager to develop more Standard Operating Procedures.

Ahmedabad, Gujarat, IN

• Work to Repair, Troubleshoot and Maintenance of biomedical equipment’s in ICU, Diagnostic and therapeutic machines according to specifications.
• Involvement in activities of the hospital’s safety committee and Inspection of safety hazards in healthcare.
• Monitor contract services viz. A.M.C. and C.M.C, documentations, and reports management.

• Firsthand experience for Engineering, Procedures, Manufacturing, and standards ofproducts in projects.
• On site guidance for testing and analysis of various medical equipment’s such as CT ScanMachines, Ventilators, Heart Lung Machine, Surgical tools, Intra-Aortic Balloon PumpCatheter

Master Of Science - Ms, Biomedical/Medical Engineering

Bachelor Of Engineering - Be, Biomedical Engineering