Krishna Sagar Kalepu
Expertise in Quality Assurance & Compliance / Investigations / Product Quality/ Validation
- Role
- Senior Quality Assurance at Moderna
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Krishna Sagar Kalepu
Versatile 9+ years of experience in the quality domain.
Experience
Senior Quality Assurance
Aug 2023 — Present · Cambridge, MA, US
Continue to improve Moderna’s overall Quality Management System (QMS) and quality manual, policies and procedures while keeping them current with emerging and changing regulations, guidance documents and current industry best practices and expectations.Provide leadership, guidance and expertise for establishment and reporting of quality metrics for GMP related functional areas.Provide quality oversight from a compliance perspective for quality control laboratories, manufacturing and overall operations to support INT at the Norwood/Burlington cGMP manufacturing facility which includes raw material, plasmid, drug substance, formulation, drug product.Drive Risk Management initiatives and manage the INT Risk Register and associated actions.Manage Self Inspection (Internal Audit) facilitation and participation.Monitor audit outcomes and findings to ensure timely CAPA follow-up.Identify opportunities for quality system improvements.Work collaboratively with the digital team on the GXP integrated digital landscape to support eDOC, eQMS, and LMS systems.Provide compliance guidance and training through various methods including formal and informal presentations and trainings.
Education
Northeastern University
Master of Science - MS, Regulatory Affairs
Andhra University
Bachelor of Pharmacy (B.Pharm.), Pharmacy
2008 — 2012
Andhra University
Master's in Pharmacy (M. Pharm.), Pharmaceutical Sciences
2012 — 2014
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.