Ramakrishna Sesham Email & Phone Number

Lake Forest, Illinois, Us

❖Develop, implement, maintain, and continually assess a quality assurance function and a qualitymanagement system for applicable regulated activities to meet internal company standards and external regulatory and customer requirements.❖Administer and execute the policies, processes & SOPs related to the development of all quality assurance activities and quality management systems. Implement short-term and long-term strategies, goals, and objectives related to the quality assurance function and the quality management system.❖Maintain a document control system for procedures, work instructions, and forms. Accountable for batch record review and disposition. Manage Deviation and Change Control programs. Assist with quality-related information related to client assessments, RFPs, contracts, and other documentation.❖Conduct incident investigations and identify related CAPA activities and processes. Drive qualityimprovements and respond to process and service issues by performing internal quality auditing (including applicable vendors or subcontractors), customer quality audit response, and other quality management system activities.❖Oversee IT systems used to support Quality activities, including Veeva, document management, quality training. Gather relevant information and author reports related to Annual Product Reviews. Conduct review of CMC sections for regulatory submissions.❖Maintain current knowledge base of regulations, corporate policies, and standards to ensure that the quality assurance function and the quality management system remain in compliance with applicable regulatory and corporate standards/requirements and best practices.

Conshohocken, Pa, Us

❖Served as GMP Change Control Manager and successfully implemented electronic quality system(MasterControl) for Change Control, Document Control, Incident/Deviations/ Nonconformance / CAPA and Complaints, while managing Governance Boards monitoring metrics for maintaining health of quality systems.❖Collaborated with IT & System Vendor to design, implement, and deliver the solution for Change Control Management, Document Control Management & Quality Event Management.❖Developed reports, based on the needs of end-users, Management, Notified Bodies, and Regulatory Authorities, to enable efficient real-time QMS reporting. Prepared status report metrics for the CAPA and Change Control systems and other relevant KPIs.❖Handled Production & Inventory Management systems. Coordinated, communicated, and resolved problems through collaboration between the Supply Chain and the customers.❖Developed training courses and modules and provided training to effectively implement the EQMS.❖Created and conducted Change Control module training as needed for stakeholders.❖Managed and oversaw the Change Control processes to ensure activities are conducted in compliance with corporate procedures and regulatory requirements.❖Acted as an SME and Single-Point of Contact (SPoC) for the configuration and validation of the Document Management System. Developed quality metrics using PowerBI and created a centralized site for the management.

Deerfield, Illinois, Us

❖Worked as Regulatory Compliance Project Lead and spearheaded a team of RA Specialists for on time project completion. Served as a key member of the Regulatory Project Management team and contributed to working with Global teams to identify, propose, develop and manage improvement projects.❖Accountable for Labeling MDR Assessment for about multiple product codes across DHF’s; Performed Global Labeling Matrix (GLAM) Assessments for EU Products; Led EU MDR labeling impact for codes sold in EU regions; and Created Labeling Requirement Specification (LRS) and Master Content Document (MCD).❖Managed DHF Remediation Project for Legacy Products in compliance with internal quality system procedures and 21 CFR Part 820.30 quality systems regulations.❖Liaised with other project managers on the team as well as regulatory operations team members in order to meet the business needs.

Commerce, Texas, Us

Hyderabad, Andhra Pradesh, In

Master Of Science (Ms), Chemistry

Bachelor Of Pharmacy (B.Pharm.), Pharmacy