Senior Executive QA Full-time Job1 week ago - Pharma - Mumbai - 17 views
- Execute the activities related Complaint Management with proficiency in using the associated tools
- Effectively use the QMS tools like TruVault, Trackwise, SUMMIT, Unity etc.
- Execute activities related to internal and supplier’s audits to assure compliance with regulatory requirements, company & 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. Shall investigate the issues and document and follow up the action plans
- Facilitate 3rd Party audits, i.e. Notified Body, FDA and other regulatory agency compliance inspections as well as Corporate audits and coordinate responses
- Prepare quality reports and develop procedures which affect operational and compliance status and coordination/preparation/presentation of management review.
- Execute the activities related to QMS elements like Document Control, Change Control, Escalations, Quality Issue Management etc.
- Prepare Management Reports (Monthly Reports, Prism / Metric Studio Reports etc.)
- Gain knowledge on ISO 13485 & 9001 standards
- Gain knowledge on Medical Device Rules 2017
- Quality systems implementation and maintenance; GMP/Quality Systems Regulations; ISO13485
- Knowledge and competency in application of Local FDA (D&C act), ISO 13485 and other regulatory requirements especially in Quality Systems.
- Excellent written and verbal communication/presentation skills necessary to meet the needs of various audiences with a demonstrated track record of strong organizational and interpersonal skills. Advanced computer skills specifically in MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
Selection Process: The selection will be on the basis of Interview.
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Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We embrace innovation—bringing ideas, products and services to life to advance the health and well-being of people around the world. We believe in collaboration, and that has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make every day a little better. Our over 125,000 employees in 60 countries are united in a common mission: to help people everywhere live longer, healthier, happier lives.