Dhundiraj Khandare
Assistant Manager @Sandoz
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WORK HISTORY
Assistant Manager @Sandoz
Maharashtra, IN
Representing the site in Health Authority, Internal, and customer inspections-Planning, participating, and monitoring self-inspections for various departments on the site-Responsible for compliance to inspections at the site and communication, including inspection logistics, front room/back-room management, receipt of inspection reports/observations, compilation of inspection response compliance reports, updating of audit approval status, training to subject matter experts, and effectiveness of compliance action-Monitoring and tracking of Health Authority/Internal inspections CAPAs, handling of Trackwise and AQWA A system / GX_QEM system initiation of CAPAs in the system as per commitment mentioned in the compliance report, follow up and ensuring closure of CAPAs as per commitments, and timely closure of corrective and preventive actions-Maintaining confidentiality and ensuring safe custody and efficient handling of company documents and materials-Monitoring and tracking of compliance activity to ensure KPI compliance at the site-SPOC for Global alerts, GQA circulars, lessons learned, etc-Creation and review of SOPs, FRMs, ATTs, WPs, QMs, QDs, and implementation of global standards at the site-Handled regulatory inspections (USFDA, EU AGES, Turkey Health Authority, Korea MFDA) with zero observations and managed customer inspections, ensuring compliance and quality standards-Support the strategic development of an effective global risk-based audit strategy and programme; collect, collate and incorporate input into audit strategy and plan.Lead, plan, conduct, document and follow-up of global quality regulatory compliance audits and assessments according to the requirements specified in the respective Quality Module as well as applicable regulations, standards, quality agreements, and guidance documents. Perform activities with a high degree of independence-Prepare audit reports according to Sandoz requirements and timelines.
EDUCATION
Savitribai Phule Pune University
M.pharm, Quality Assurance
SKILLS
ABOUT DHUNDIRAJ KHANDARE
As a Site QA Manager with M.Pharm in Quality Assurance, I bring extensive expertise in…
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