Divyashree Hn

Quality Assurance professional with over 3 years of combined experience across pharmaceutical and medical device industries, with hands-on experience supporting Supplier Management programs including supplier qualification, audit coordination, SCAR (Supplier Corrective Action Request) management, and Approved Supplier List maintenance. MDSAP-trained internal auditor experienced in document control, CAPA/non-conformance management, deviation and change control handling, regulatory gap assessments (QMSR / 21 CFR Part 820), and KPI reporting to key stakeholders. Skilled in working independently in fast-paced, regulated environments with strong attention to detail and cross-functional coordination.

QMS Executive - Fourth Frontier Technologies Pvt. Ltd. - Bengaluru, India

(2024-10)

• Support supplier management activities including supplier qualification, audit coordination, and SCAR (Supplier Corrective Action Request) management, working toward maintaining an up-to-date Approved Supplier List.
• Coordinate supplier/vendor audits and external, notified body audit activities within an ISO 13485 and MDSAP-certified quality management system.
• Log, track, and investigate root causes for CAPAs and non-conformances (NCs); coordinate with cross-functional teams to drive timely closure.
• Conducted gap assessment against QMSR (21 CFR Part 820) requirements and updated relevant SOPs to align with findings.
• Gained working exposure to US FDA 510(k) submission documentation through cross-functional collaboration with senior regulatory team members.
• Manage end-to-end document control, including issuance, retrieval, and updates of controlled documents in line with SOPs.
• Participate in internal audits and contribute to quality system activities as the organization progresses toward EU MDR compliance.

QA Executive - Analytica Chemie Inc. - Bengaluru, India

(2022-01 - 2024-10)

• Conducted vendor qualification activities and supported supplier compliance documentation.
• Completed customer audit questionnaires and compiled supporting documentation for compliance.
• Handled deviations, incidents, and change controls in accordance with quality procedures.
• Prepared, reviewed, and issued Standard Operating Procedures (SOPs).
• Reviewed analytical raw data and Certificates of Analysis (COA) for accuracy and compliance.
• Coordinated as Training Management Coordinator, tracking and organizing employee training records.
• Managed document control processes: issuance, retrieval, and updating of documents per SOP.
• Coordinated internal, customer, and regulatory audits, ensuring readiness and timely responses.

M.Sc. - Chemistry - Mangalore University (2021-11)