Vikrant Mishra
MS in Regulatory Affairs Student at Northeastern University.
- Role
- Quality Assurance Specialist at Massachusetts General Hospital
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Vikrant Mishra
A proactive individual who believes in doing work at the earliest. An optimistic…
Experience
Quality Assurance Specialist
Massachusetts General Hospital
Jun 2024 — Present · Danvers, MA, US
Revamped QMS documentation and collaborated with cross-functional teams to develop and update SOPs, enhancing compliance traceability and reducing audit findings. Authored batch review reports, CAPA documentation, and quality summary records, providing expert guidance on cGMP principles and FDA/ISO requirements to support continuous improvement initiatives. Managed document control activities in line with GDP standards, including version control, archiving, and ensuring audit-readiness for regulatory submissions and inspections. Executed statistically driven in-process sampling protocols and line clearance inspections, improving QA resource utilization by 25% and shortening batch release timelines by 15%. Initiated and tracked CAPAs in response to audit findings and product non-conformities, conducting root cause analysis and ensuring timely closure with sustainable corrective actions. Collaborated with contract manufacturers and raw material suppliers to address recurring quality issues and ensure compliance- driven performance improvements. Facilitated cross-functional sessions to define Critical Quality Attributes (CQAs), enhancing consistency during packaging line inspections and final product releases.
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