VENKANNABABU V

Company Overview: Customer ABBOTT VASCULAR

• To create/ update artwork, labels, IFUs, Implants, eIFU & ePG for design as per redlining documents through Labeling Software and Abode Illustrator, for the Cardio-Vascular division, and to perform Artwork Mechanical Check using SOPs and WI document, Proofreading using DOP, Affiliate review, CO review/ approval and artwork package - FTP
• Products: Guidewire, Stent, Xience, Omnilink Elite, Herculink Elite, Supera, Absolute Pro & Hi-Torque
• Customer Abbott laboratories

• Company Overview: Client Johnson & Johnson DePuy Synthes
• As a Senior Engineer in (Integrated Change Management) team, I was responsible for coordinating MDD & MDR Medical Device labels & ECOs Creation in PLM Software and assigning with respective stakeholders regularly to get the approvals on time as per the given timelines
• Coordinate with the labeling lead & get trained in labeling PLM software(s) and applicable standards
• Work closely with the project leader's new product development and existing teams
• MDD & MDR ISO 13485, 13488, 510(K), CE Marking, Standard Labels in the creation, design, and implementation of product labeling and packaging graphics
• With in-line to regulated markets (USA, Canada, EU, Brexit, and ROW)
• Develop/create graphic file work (InDesign or other systems) as needed for product labeling and packaging graphics
• Initiate documentation packages for artwork approval
• Artwork production services consisting of electronic creation of artwork files for all labeling needs, downloads and uploads of digital artwork files, file management of die line files, font management, troubleshooting synchronicity issues with partner suppliers
• Work within labeling tools/systems to modify/create label templates
• Create and manage changes within the labeling system
• Label request form creation
• Involved in executing ECOs & IFUs for processing labels but not limited to creating red lines, changing order forms, creating redlines, label request forms, etc
• Coordinate with all stakeholders for timely approval of Change Assessments and Change Orders
• Provide support to proofing of labels as and when required
• Release artwork and maintain native artwork files
• Maintain track of projects within the timelines with the current status
• Develop metrics and reports for the artwork approval timelines
• Support for end-to-end PLM's approval and process
• Client Johnson & Johnson DePuy Synthes

• As an Executive - Packaging Development, I was responsible for coordinating Health Care products designing artworks, Cartons, Blister & PIL labels for assigning to respective stakeholders regularly as per the given timelines
• Designed layout or Cutter guides and graphics and prepared for print
• Worked as a core part of QAMS-Quality Assurance Management System
• Coordinating with stakeholders in case of any comments
• Maintain track of projects within the timelines with the current status
• Provide reports for senior management with project/artwork status
• Sending FMP files (Hi-Res files) to suppliers through the Product Lifecycle Services System
• Meet with respective cross-functional teams and clients to review and revise the artwork
• Sending final approved artwork copies to the Sourcing/Planning Team

• Company Overview: Client Johnson & Johnson
• Manage the end-to-end process for documenting, approving, and implementing Labeling changes in the ETQ Global Change Control (GCC) system
• Ensure all required inputs (i.e., Forms) have been received and approved, if necessary, before initiation of a GCC
• Review all required inputs (i.e., Forms) to ensure a complete understanding of the change and connect with the Label Service Coordinator(s) if clarification is required
• Utilize required inputs (i.e., Forms) and Good Documentation Practices to record the specific, detailed change information in the GCC Initiation
• Identify the appropriate Subject Matter Experts (SMEs) and Plan Approvers in the GCC
• Description of Current State
• Description of Proposed State
• Rationale / Justification for Change Impact Assessment
• Implementation Strategy
• Utilize inputs (i.e., Forms) to enter the required deliverables and timing in the GCC
• Route the GCC for review/approval through the GCC system
• Follow up with SMEs and Approvers to ensure timely completion of reviews/approvals in the GCC system
• Provide GCC status updates (as appropriate) to the Label Service Coordinator(s) throughout the change control process
• Client Johnson & Johnson

• Company Overview: Client Johnson & Johnson
• As a Senior Executive of Regulatory Operations, I was responsible for coordinating the Artworks and proofreading artworks assigning them to the respective stakeholders regularly as per the given timelines
• Worked as a core part of QMS-Quality Management System
• Responsible mainly for review and update of the Company Core Data Sheets (CCDS) for Consumer products
• Coordinating with Regulatory, Marketing, Artwork, and Medical Affairs team members for artwork change approvals
• Assignment of Artwork and timelines of each project based on the standard timeline
• Assignment of approvers based on the approval matrix
• With in-line to regulated markets (Asia Pacific, Australia, USA, Canada, EU, and ROW)
• Coordinating with stakeholders in case of any comments conflict in the cocoon system
• Acts as the communication bridge between all stakeholders
• Sending FMP files (Hi-Res files) to the supplier through the COCOON System
• Digital proof files have been Approved/Rejected in the COCOON System
• Point of contact for any artwork and process-related questions
• Maintain track of projects within the timelines with the current status
• Develop metrics and reports for the artwork approval timelines
• Provide reports for senior management with project/artwork status
• Support for end-to-end COCOON approval and process
• Client Johnson & Johnson

• Company Overview: Client Johnson & Johnson Baby Care
• As an Artwork Coordinator, I was responsible for coordinating the Artwork Approvals with respective stakeholders and regularly getting the approvals on time as per the given timelines
• Coordinating and following up for the artwork approval with respective stakeholders within Johnson & Johnson daily by accessing the COCOON System
• Creating product code in the PLM tool
• Maintain track of projects within the timelines with the current status
• Develop metrics and reports for the artwork approval timelines
• Provide reports for senior management with project/artwork status
• Sending FMP files (Hi-Res files) to the supplier through the COCOON System
• Digital proof files have been Approved/Rejected in the COCOON System
• Sending final approved artwork copies (CG Specs) to the Sourcing/Planning Team
• Admin support for the end-to-end approval process
• Single point of contact across J&J India for any artwork status-related queries
• Client Johnson & Johnson Baby Care