Reni Nedumkallel, Eit Email & Phone Number

Toronto

• Manage change control records for various change types, including discontinuation, equipmentchanges, process changes, and document and master data changes. Develop background, change scope, and rationale in accordance with GMP guidelines and regulatory compliance.• Engage with stakeholders and area leaders to ensure change impacts are clearly defined and assessed.• Coordinate communication between all stakeholders to ensure change is implemented ina timely manner. This includes organizing and leading online and offline meetings.• Extract data from databases, analyze and present specific results to stakeholders in the form of metrics for tracking change control timelines, regulatory submissions, and ongoing product changes.• Subject matter expert for several areas including product discontinuation, shelf lifeextension, and tablet embossing.• Developed training plans and trained several colleagues, both on-site and overseas.

As project lead for Document Conversion Project:• Developed new lean production templates by liaising with subject matter experts,quality assurance department, production managers, and production techniciansefficiently within extremely tight timelines• Developed training courses and trained departments on-site and overseas• Worked with QA and template users from all impacted departments to providecontinuous support throughout document conversion processAs Interim SAP DMS Specialist:• Creation and revision of form categories in SAP for all processes and plants• Ensuring timely updates of forms to prevent downtime• Performing SFA/QFA test cases for dynamic forms• Creating new product acronyms and maintaining Apotex Product Acronym List• Lead continuous improvement projectsAll other Technical Writer duties:• Conducting detailed impact analysis for Master Production Documents and PackingOrder Masters according to proposed Request for Change• Create and update master documents as outlined in the Change Control while alsoensuring compliance with all SODs and GMPs• Review the accuracy of all manufacturing and packaging instructions• Initiate required changes in change management system and provide sufficient detailand rationale for the changes• Act as liaison between Change Owner and QA Document Reviewer to make correctionsand approve the documents for use on the production/packaging floor

• Generated and managed production documentation through SAP• Reviewed completed production documents and released products for shipping• Built product display samples independently and submitted for client approval• Trained production staff on correct assembly of products• Performed management of inventory with regards to damages, rejects, and holds• Performed receiving and inspection of incoming items• Performed QA checks including line approval, line clearance, and hourly inspection• Generated NCR and initiated complaints as required

• Supervised and facilitated weekly production at five different meat manufacturing facilities• Performed quality assurance analysis on-site to make rapid adjustments to production process• Provided support for production through technical analysis of equipment in process flow• Documented technical research material for operation of various equipment• Worked with team members to create and improve new and existing product formulations• Tested product formulations and performed chemistry analysis in on-site kitchen• Reported to multiple team members daily for various projects including pilot scale production• Organized daily meetings and communicated with suppliers, clients, and plant personnel• Completed scientific reports after data collection and analysis from production tests