AMEY CHAWAK
North Ridgeville,OH
Summary
Growth-focused, seasoned professional with extensive experience in all aspects of serialization and regulations. Vast experience in Pharmaceutical domain with a flavour of IT back ground. Aiming to leverage my knowledge of Serialization Regulation and serialization technologies to make an immediate contribution to your organization.
Overview
19
19
years of professional experience
1
1
Certification
Work History
VICE PRESIDENT
SERIALIZATION, EVERSANA
01.2018 - Current
- Lead, coordinate and manage consistent delivery of solutions for Eversana’s serialization needs with focus on overall solution leadership
- Provide direct leadership to Serialization team and lead various technology integrations
- Interpreting and guiding product launch teams on regulatory requirements US DSCSA deliver solutions with integration to ERP and current serialization solution providers
- Serve as a global expert on Eversana Serialization processes for IT systems, lead the process analysis and design, gap analysis and change management exercises in support of the harmonization of business processes
- Leading the launch team from serialization readiness
- Acting as a point of contact for CMO/Business vendors
- Representing Eversana in FDA, customer audits
- Implement and manage a project governance framework for customer or partner engagements
- Provide clear and effective internal and customer-facing communication and escalation paths and processes
- Execute cross-functional, cross-product awareness and coordination of the customer's service experience, priorities, and needs
- Adhere to all relevant regulatory and procedural requirements and guidance in the conduct of projects in an information- enabled environment.
SERIALIZATION LEAD -IT BUSINESS SPECIALIST
Xellia Pharmaceuticals USA
11.2018 - 09.2023
- Lead, coordinate and manage consistent delivery of solutions for Xellia's serialization needs with focus on overall global solution leadership
- Acting as platform technology owner for all the serialization platforms like E1, Rfxcel,TraceLink, Uhlmann Site Servers and various L2/L3 vendors
- Provide direct leadership to NA Serialization team and lead various technology integrations
- Interpreting and guiding product launch teams on regulatory requirements (US DSCSA, EU FMD, Brazil ANVIA,Russia CRPT, Egypt EDA) and deliver solutions with integration to ERP and current serialization solution providers
- Serve as a global expert on Xellia's Serialization processes for IT systems, lead the process analysis and design, gap analysis and change management exercises in support of the global harmonization of business processes
- Participating in the Packaging line update of site servers for optimized production
- Leading the launch team from serialization readiness
- Acting as a point of contact for CMO/Business vendors
- Representing Xellia in FDA, customer audits
- Implement and manage a project governance framework for customer or partner engagements
- Provide clear and effective internal and customer-facing communication and escalation paths and processes
- Execute cross-functional, cross-product awareness and coordination of the customer's service experience, priorities, and needs
- Adhere to all relevant regulatory and procedural requirements and guidance in the conduct of projects in an information- enabled environment.
Implementation Project Manager(Consultant)
Traclink Inc
01.2016 - 01.2018
- Manage end to end implementation of the Tracelink Serialization Platform for the various Pharma companies
- Understanding customer's business, launching methods, supply chain to understand serialization requirements
- Integrate multiple pharmaceutical companies, contract manufacturing organizations, and trade partners onto the
- TraceLink enterprise SaaS product
- Provide online and onsite training for product installation while conveying best practices to ensure a solution that exceeds
- Industry standards
- Design project plans to meet implementation milestones, manage risk, and inform project members
- Provide project leadership for customer and partner integrations
APPLICATION LEADER/PROJECT LEADER
KeyBank Inc
01.2012 - 01.2016
- Implement and manage a project governance framework for customer or partner engagements
- Develop, manage and report on project status, schedule and risks
- Provide clear and effective internal and customer-facing communication and escalation paths and processes
- Execute cross-functional, cross-product awareness and coordination of the customer's service experience, priorities, and needs
- Adhere to all relevant regulatory and procedural requirements and guidance in the conduct of projects in an information- enabled environment
- Subject Matter Expert – Wealth, Management: Manage production support activities of various applications
- Manage Ticket Tracking and SLA matrix
- Production Support and Compliance Activities: Perform System Analyst role for critical applications in the portfolio related to Wealth Domain Design & Documentation: Create functional specification documents by interacting with the clients and Understanding their requirements
- Create high level, detailed technical design document to design fields from Various data sources, business rules, process flows and entity relationship Diagrams
- Planning and Controlling: Providing release plan and implementing releases periodically
- Communication & Co-ordination: Working with various teams (Testing, Security etc.) and arranging necessary logistics for controlled and planned deployments.
SOFTWARE DEVELOPER, TEAM LEADER
Genworth
01.2009 - 01.2012
- Analysis and Development: Responsible for handling small enhancement in J2EE, Struts along with providing
- WebSphere
- Administration support for the application
- Design & Documentation: Create functional specification documents by interacting with the clients and
- Understanding their requirements
- Create high level, detailed technical design document to design fields from Various data sources, business rules, process flows and entity relationship Diagrams.
SOFTWARE ENGINEER
Patni Software
01.2005 - 01.2009
- Analysis and Development: Responsible for handling small enhancement in J2EE, Struts along with providing
- WebSphere
- Administration support for the application
- Technology used: Java, JSP, Servlets, JavaScript, Unix Scripts, Sybase, IBM FileNet Design & Documentation: Create functional specification documents by interacting with the clients and Understanding their requirements
- Create high level, detailed technical design document to design fields from Various data sources, business rules, process flows and entity relationship Diagrams
Education
MASTER - APPLICATIONS
PUNE UNIVERSITY
BACHELOR OF COMMERCE -
Pune University
Skills
- Global Serialization Regulations
- Agile And Scrum Methodologies DSCSA And FDA Regulations
- Cross-Functional Team Leadership And Collaboration Product Implementation GS1 EPCIS
- EPCIS, GS1
Certification
Professional Scrum Master
Timeline
SERIALIZATION LEAD -IT BUSINESS SPECIALIST
Xellia Pharmaceuticals USA
11.2018 - 09.2023
VICE PRESIDENT
SERIALIZATION, EVERSANA
01.2018 - Current
Implementation Project Manager(Consultant)
Traclink Inc
01.2016 - 01.2018
APPLICATION LEADER/PROJECT LEADER
KeyBank Inc
01.2012 - 01.2016
SOFTWARE DEVELOPER, TEAM LEADER
Genworth
01.2009 - 01.2012
SOFTWARE ENGINEER
Patni Software
01.2005 - 01.2009
MASTER - APPLICATIONS
PUNE UNIVERSITY
BACHELOR OF COMMERCE -
Pune University