Quality Assurance Regulatory Compliance

Divya Jyothi Gajavalli

https://www.linkedin.com/in/divya-jyothi-gajavalli +1-412-***-**** **************@*****.*** Boston, MA Professional Summary: Results-driven Pharmacovigilance (PV) professional with years of experience in PV auditing, regulatory compliance, and quality assurance. Adept at managing global audits, regulatory inspections, and CAPA processes. Strong expertise in Good Pharmacovigilance Practices (GVP) and Good Clinical Practices (GCP), with a proven ability to drive risk-based quality oversight. Skilled in vendor management, process improvements, and regulatory authority interactions. Education:

Northeastern University, Boston - Masters of Regulatory Affairs, GPA: 3.7/4.0 GIET School of Pharmacy, Rajahmundry - Bachelor of Pharmacy Core Competencies and Technical Proficiencies:

• Regulatory Compliance & Submissions: FDA 21 CFR 820, ISO 13485, ISO 9001, CE Marking, eCTD submissions.

• Quality Assurance & Risk Management: CAPA, GUDID database, Internal Audits, Regulatory Inspections

• Regulatory Documentation & Labeling: SOP Development, Promotional Material Review, Technical File Maintenance

• software & Compliance Tools: eCTD Software, QMS Systems, Adobe Acrobat, Microsoft Office Suite

• Project Management & Communication: Cross-Functional Collaboration, Regulatory Training, Risk Assessment

• Tools: Microsoft Office Suite (Word, Excel, PowerPoint), lean six sigma, Agile Methodologies, Master control, Doc-Star, Veeva Vault, Argus., EUDAMED mobile applications, Master control, Argus, Aris G,HIBC,UDI-DI Professional Experience:

Quality Assurance/RA Associate, Spectra Medical Devices, USA Jan.2025-Current

• Assisted in conducting internal PV audits and supported regulatory compliance initiatives.

• Contributed to the preparation of inspection documentation and audit reports.

• Monitored CAPA implementation and follow-ups to ensure compliance with regulatory expectations.

• Maintained and updated quality assurance trackers and audit schedules.

• Maintained current knowledge base of existing and emerging regulations, standards, and guidance documents related to biological products, medical devices, and IVDs.

• Managed technical files and certificate of suitability (CEP) filing with EDQM. Regulatory affairs CO-OP, Spectra Medical Devices, USA. Jul.2024-Sep.2024

• Supported PV audit planning and execution by gathering relevant documentation and regulatory references.

• Assisted in vendor audits, ensuring alignment with GVP and company SOPs.

• Helped maintain the QA database and tracked audit findings and resolutions.

• Conducted quality checks and ensured documentation accuracy for regulatory submissions.

• Assisted with eCTD formatting, technical review, and publishing for regulatory agency submissions.

• Maintained GUDID database for US UDI compliance and tracked regulatory updates. Pharmacovigilance Associate 1, PAREXEL, Hyderabad Feb.2022-May.2023

• Lead and coordinate global PV audits, ensuring compliance with GVP and regulatory guidelines.

• Prepare for and host regulatory authority inspections, including response preparation and CAPA tracking.

• Review, approve, and oversee the implementation of CAPAs to ensure timely resolution of audit findings.

• Maintain QA databases and audit trackers to reflect the status of scheduled audits.

• Manage vendor quality oversight and ensure compliance with safety reporting requirements.

• Assisted in audits and regulatory filings to ensure adherence to ISO 13485 and FDA 21 CFR 820.

• Reviewed and updated SOPs to align with regulatory changes and quality management standards.

• Demonstrated proficiency in drug safety software systems, ensuring efficiency in pharmacovigilance workflows.

• Led QC investigations and site follow-ups on missing or incomplete drug safety reports, ensuring data integrity. Safety Trainee, IQVIA, Bengaluru

• Developed and implemented risk-based quality oversight strategies to enhance compliance.

• Conducted PV process and system audits, ensuring adherence to SOPs and regulatory requirements.

• Developed and implemented risk-based quality oversight strategies to enhance compliance.

• Assisted in managing GCP regulatory inspections, providing PV-related QA support.

• Collaborated cross-functionally to ensure regulatory compliance and continuous improvement. Projects:

• Facilitated in the implementation of HIBC barcode labeling standards for Class II and III devices. successfully managed UDI-DI tracking for multiple medical devices, improving compliance and traceability.

• Reviewed and updated regulatory standard operating procedures (SOPs) to align with industry best practices.

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