sriharsha.bellamkonda

Manage specification, qualification and validation requirements. Write and execute engineering change orders related to Corrective and Preventive Actions (CAPAs), changes in Critical to Quality (CTQs), release of aging reports, updates to design history files. Conduct Risk based verification for GxP (GMP, GCP, and GLP) systems and laboratory equipment. Create, and update Failure Mode and Effect Analysis (DFMEA) for new implants and instruments. Design, develop and oversee validation components and work on inspection plans and Inspection Feature Assessment.

Gather requirements, develop, and maintain web and client server applications. Create custom objects, custom fields, page layouts, custom tabs and reports. Develop applications based on object oriented programming concepts. Implement complex queries, store procedures, views, triggers, cursors, joins and constraints. Deploy code on servers with various encryption technologies

Develop and implement standard operating procedures (SOPs) and quality management Systems (QMS) using ISO 13485/21/CFR part 820, cGMP compliance and other regulatory standards. Develop Process Flow diagram (PFD), Process Failure Mode Effect Analysis (PFMEA) and Quality control plans. Execute validation activities for IQ/OQ/PQ/TQ. Prepare Non-conformance Material Reports (NCMR).

Involve in all phases of Software Development Life Cycle. Design and develop user interfaces and web-client server applications as per business and functional requirements. Implement complex queries, store procedures, views, triggers, cursors, joins and constraints. Perform code review and debug prototype designs. Troubleshoot, identify defects, and fix them.

Involve in all phases of Software Development Life Cycle. Design and develop user interfaces and web-client server applications as per business and functional requirements. Implement complex queries, store procedures, views, triggers, cursors, joins and constraints. Perform code review and debug prototype designs. Troubleshoot, identify defects, and fix them.

Write, modify and execute engineering change orders related to Corrective and Preventive Actions (CAPAs), changes in Critical to Quality (CTQs), release of aging reports, and updates to design history files. Design, develop and oversee validation components. Conduct Risk based verification for GxP (GMP, GCP, and GLP) systems and laboratory equipment. Create, and update Failure Mode and Effect Analysis (DFMEA).

Develop and implement standard operating procedures (SOPs) and quality management Systems (QMS) using ISO 13485/21/CFR part 820, cGMP compliance and other regulatory standards. Develop Process Flow diagram (PFD), Process Failure Mode Effect Analysis (PFMEA) and Quality control plans. Execute validation activities for IQ/OQ/PQ/TQ. Prepare Non-conformance Material Reports (NCMR).