Swarna Raj
Quality specialist | ISO-9001 ISO-13485 | Audit and Compliance| GMP | Documentation and Reporting @AMS Solution
- Role
- Qa Specialist at Advanced MedTech Solutions (AMS)
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
Experience
Qa Specialist
Advanced MedTech Solutions (AMS)
Feb 2025 — Present · Gurugram, IN
Implement and maintain the Quality Management System (QMS) in compliance with ISO 13485 and ISO 9001 applicable regulatory standards. Prepare and manage quality documents such as SOPs, work instructions, and quality manuals. Conduct internal audits, support external audits, and ensure timely closure of non-conformities. Review and approve batch manufacturing records, validation protocols, and reports. Coordinate CAPA, deviation, and change control processes. Ensure document control and maintain master document lists. Monitor and report on quality metrics and support continuous improvement initiatives. Collaborate with cross-functional teams to ensure regulatory compliance and product quality. Train staff on quality procedures and regulatory requirements.10. Responsible for Vendor Mangement.
Education
DIT UNIVERSITY
M. Pharm
2018 — 2020
DIT UNIVERSITY
Bachelor of Pharmacy
2014 — 2018
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