Hire Sudhakar B, a pharma consultant specializing in Medical Devices and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Sudhakar B is a quality assurance professional with experience in medical device projects, software development processes, and IT services. His expertise includes quality management systems, corrective and preventive actions (CAPA), complaints handling, change management, and quality assurance. At HCL Technologies, he supports medical projects through internal audits, external audit coordination, supplier corrective action tracking, and quality process reviews. His background includes ISO 13485 and ISO 9001 internal auditing, root cause analysis, documentation updates, and quality training. He helps teams strengthen process controls, maintain traceable quality records, investigate complaints, and monitor corrective actions through closure and effectiveness checks. - Show More
Sudhakar supports CAPA activities through root cause analysis, corrective action implementation, effectiveness checks, and closure tracking. His experience includes complaint investigations and supplier corrective action requests. He uses tools such as 5 Why and Pareto analysis to investigate quality issues and helps teams document actions addressing their underlying causes.
Sudhakar supports change management through Change Control Board activities, review of change requests, and documentation of project and product changes. His experience includes design changes, remediation-related document updates, and assessment of lifecycle impacts within medical device projects. He helps teams maintain controlled and traceable implementation of approved changes.
Sudhakar supports complaint handling through complaint lifecycle coordination, investigation, root cause analysis, and corrective action follow-up. His experience includes medical project complaint processes and customer complaints within service operations. He helps teams maintain investigation records, track resolution activities, and assess the effectiveness of actions taken.
Sudhakar supports quality assurance for medical device and software-related projects through process compliance reviews, internal audits, quality metric monitoring, and audit preparation. His experience spans Agile and non-Agile software development lifecycles. He also delivers training on quality systems, CAPA, and audit readiness to help teams apply established procedures consistently.
Sudhakar supports quality management systems for medical device projects and service operations through process reviews, internal audits, SOP preparation, and documentation updates. His experience includes ISO 13485 and ISO 9001 systems, external audit coordination, and employee training. He helps teams identify process gaps, maintain quality records, and follow up on corrective actions.
