Arzoo Khare

As a Quality Assurance Specialist, I manage regulatory and GMP audits and ensure compliance with regulatory standards. I manage and actively participate in deviations, change requests, and market complaints, ensuring timely CAPA implementation. I lead a team of In-Process QA and validation, overseeing process, equipment, and system validation while ensuring accurate documentation. I conduct risk assessments, troubleshoot issues, and drive continuous improvement initiatives. I review validation documents and qualifications for computerized system audits. Additionally, I collaborate with auditors during FDA and other regulatory audits, including USFDA, MHRA, and WHO.

As an Internal Auditor and QMS Investigator, I conduct thorough GMP audits, ensuring compliance with regulatory standards and internal policies across Cipla sites. I had lead investigations for deviations, performed root cause analysis, and oversee corrective actions within the QMS framework. I manage change requests, market complaints, and ensure Data Integrity compliance. Additionally, I review validation and qualification documents, supporting regulatory audits and global CAPA implementation. Participated in APQR compilation and review process.

Accounted for a Quality Control and micro planner, I manage the planning and scheduling of QC activities to ensure timely and accurate testing of products. I coordinate with cross-functional teams to prioritize tasks, maintain testing workflows, and ensure compliance with regulatory standards. I monitor the performance of QC processes, implement improvements, and manage documentation for audits. Additionally, I oversee the preparation and maintenance of quality control records to support continuous improvement and regulatory compliance.