Rachel Princess
Senior Executive Quality Assurance @Johnson & Johnson MedTech
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WORK HISTORY
Senior Executive Quality Assurance @Johnson & Johnson MedTech
Mumbai, IN
Organize, plan and lead the execution and compliance related to Product Complaint Management with proficiency in using the associated tools.• Responsible for the Stop shipment and Field action management for India and Affiliate markets.• Organize, plan and lead the execution and compliance related to quality system elements like Change control, Escalations, etc.• Effectively use the quality tools such as ECM,TruVault, Tackwise, SUMMIT etc.• Execute activities related to internal and suppliers audits to ensure compliance with regulatory requirements, company and international standards. • Organize, plan, lead and manage quality-related projects in alignment with Organization goals.• Responsible for the document control, CAPA, NCR and complaint analysis systems and processes. Investigating the issues and document the follow up action plans. Review reports findings and makes recommendations for corrective action• Facilitate 3rd Party audits, i.e. Notified Body, FDA and other regulatory agency compliance inspections, internal and supplier’s audits as well as Corporate audits and coordinate responses.• Attend applicable training sessions as well as complete mandatory trainings on-line e-University /Learning Management Systems and submit training records to the supervisor / franchise secretary and work as per the applicable SOPs and guidelines• Prepare Management Reports/ Monthly Report/ CQ Highlights
EDUCATION
Institute of Good Manufacturing Practices
Post Graduate Diploma, Good Manufacturing Practices
Vivek College
HSC, Science
Our Lady Of Remedy High School
SSC, High School
Sophia College, Mumbai
Post Graduate Diploma, Quality Assurance
Royal College
Bachelor's Degree, Biotechnology
SKILLS
ABOUT RACHEL PRINCESS
Experienced QUALITY PROFESSIONAL with over 10+ years of experience. Growth oriented, significant contribution to the success of the organization. Creative solutions to challenges faced. Proactive approach to explore, innovate & excel in attaining organizational goals. List of activities handled are as below:1. Developing and implementation of Quality Metrics model. Digital initiatives including usage of Microsoft office, Power Apps, Power BI, etc.3. Handling of multiple QMS activities like Product complaint management, Training, Change Control, Field Action, Vendor Management, Cold Chain Management, Drug Safety Division QA, SOP, Risk Management, Gap Assessment, etc.4. Hosting Quality Council, QSMR, Quality reviews, etc. including deck preparation, presentation, action plan, follow-up, etc.5. Collaboration with internal and external stakeholders.6. Planning, arranging, and coordinating various events like Offsite, Quality Day/Month, etc.
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