Ramakrishna Sesham

Ramakrishna Sesham Email and Phone Number

Senior Manager Information & Systems Strategy at Astellas Pharma US @ Astellas Pharma
Ramakrishna Sesham's Location
Greater Chicago Area, United States, United States
Ramakrishna Sesham's Contact Details

Ramakrishna Sesham personal email

n/a
About Ramakrishna Sesham

❖ So many things can make an enormous impact on the lives of those who surround us. The ability to be able to share knowledge, experience, and leadership is beneficial to those on both the giving and receiving ends. ❖ My passion is being able to make a difference in the lives of those I touch, positively affecting my colleagues’ development while serving as an advisor, mentor, and teacher.❖ I love to network and collaborate with my team to exceed our goals. I strive at making and building relationships. By gathering knowledge and new resources that I can share with others, I am able to affect significant and positive change.❖ I feel it is imperative to lead by positive example. My aim is to allow others to manage their own responsibilities, motivating them toward the fruition of their goals. I believe that hard work is the cornerstone to success. ❖ My results-driven work ethic is evident, and I keenly aware of my organization’s culture. My financial budget acumen, negotiation skills, and facilitation abilities put me a step above. ❖ As a Transformational Leader, I can show you how to grow ideas into sustainable business models, trigger growth and move beyond legacy product, and service thinking. ❖ As an innovative Change Management Leader, I provide guidance and structure to help businesses achieve actionable, goal-driven results and cultural change. I recognize that everyone is capable of achieving something great, if you let them. It is all about finding the right task and the potential to grow within those tasks that makes a team successful. ❖ I believe that you are not a leader before you make others become leaders. Seeing current and former colleagues and students achieve fantastic goals brings me the greatest satisfaction, and motivates me to keep learning and improving my skills.Connect with me to get the detailed exposure as Quality System Manager. Seeking to apply my knowledge and experience and continually develop my analytical and technical abilities in a pharmaceutical manufacturing or clinical development environment where growth, initiative, attention to detail, and improvement are valued and encouraged.

Ramakrishna Sesham's Current Company Details
Astellas Pharma

Astellas Pharma

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Senior Manager Information & Systems Strategy at Astellas Pharma US
Website:
astellas.com
Employees:
11726
Ramakrishna Sesham Work Experience Details
  • Astellas Pharma
    Astellas Pharma
  • Astellas Pharma
    Senior Manager Information & Systems Strategy
    Astellas Pharma Aug 2021 - Present
  • Spectrum Pharmaceuticals, Inc.
    Quality Systems Manager
    Spectrum Pharmaceuticals, Inc. Sep 2020 - Aug 2021
    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.
  • Amerisourcebergen
    Gmp Change Control Manager (Quality Systems Manager)
    Amerisourcebergen Oct 2018 - Aug 2020
    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.
  • Baxter International Inc.
    Regulatory Compliance Project Lead/Project Manager
    Baxter International Inc. Apr 2014 - Oct 2018
    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.
  • Texas A&M University-Commerce
    Graduate Research And Teaching Assistant
    Texas A&M University-Commerce Jun 2012 - Dec 2013
    Commerce, Texas, Us
  • Ravoos Laboratories Limited
    Qa Analyst
    Ravoos Laboratories Limited Nov 2010 - Nov 2011
    Hyderabad, Andhra Pradesh, In

Ramakrishna Sesham Skills

Quality Control Six Sigma Project Management Plm Tools Product Lifecycle Management Change Control Trackwise Supply Chain Management Rational Doors Fmea Dmaic Root Cause Analysis Capa Sharepoint Microsoft Project Udi Research Mass Spectrometry Uv/vis Spectroscopy Dissolution Project Planning Analytical Skills Microsoft Office Quality Assurance Cross Functional Team Leadership U.s. Food And Drug Administration Gmp Business Process Improvement Quality System Validation Medical Devices Problem Solving Design Control Regulatory Affairs Team Leadership Management Iso 13485 Analytical Chemistry Spectroscopy Power Bi

Ramakrishna Sesham Education Details

  • East Texas A&M University
    East Texas A&M University
    Chemistry
  • Acharya Nagarjuna University
    Acharya Nagarjuna University
    Pharmacy

Frequently Asked Questions about Ramakrishna Sesham

What company does Ramakrishna Sesham work for?

Ramakrishna Sesham works for Astellas Pharma

What is Ramakrishna Sesham's role at the current company?

Ramakrishna Sesham's current role is Senior Manager Information & Systems Strategy at Astellas Pharma US.

What is Ramakrishna Sesham's email address?

Ramakrishna Sesham's email address is rs****@****gen.com

What schools did Ramakrishna Sesham attend?

Ramakrishna Sesham attended East Texas A&m University, Acharya Nagarjuna University.

What skills is Ramakrishna Sesham known for?

Ramakrishna Sesham has skills like Quality Control, Six Sigma, Project Management, Plm Tools, Product Lifecycle Management, Change Control, Trackwise, Supply Chain Management, Rational Doors, Fmea, Dmaic, Root Cause Analysis.

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