Shabnam Dashti
Deviation Investigator @Resilience
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WORK HISTORY
Deviation Investigator @Resilience
ON, CA
o Author detailed deviation reports ensuring precision in root cause analysis and compliance with regulatory standards during audits and inspections.o Lead cross-functional investigations in aseptic manufacturing environments, applying advanced RCA methodologies to identify systemic gaps and implement effective CAPAs.o Analyze aseptic process behaviors and contamination risks to identify root causes of sterility-related deviations, driving CAPA or continuous improvement initiatives aligned with FDA and global regulatory requirements.o Utilize advanced technical knowledge and analytical frameworks to independently resolve complex operational and quality challenges, improving compliance, efficiency, and inspection readiness.o Collaborate with cross-functional teams to streamline investigations and maintain compliance with GMP, QMS and sterility assurance standards.o Present investigation outcomes and CAPA plans to senior management and the client representatives,contributing to improved audit readiness and compliance metrics.
EDUCATION
Islamic Azad University, Science And Research Branch
Master of Science - MS, Polymer engineering/ Processing
ABOUT SHABNAM DASHTI
Motivated QA professional with 8+ years of experience in pharmaceutical manufacturing and packaging sites. Proficient in GMP, regulatory compliance, and working with pharmaceutical drugs, medical devices, and combination products. Skilled in excelling in diverse quality roles. Known for detail- oriented, clear and logical problem-solving mindset.Expertise spans in areas: • Quality & GxP oversight (cGMP/GLP/GDP)• Deviations & CAPA management• Quality Risk Management (QRM)• Change Control• Data Integrity• Audit & Inspection (self-auditing and supplier auditing)• ICH – WHO – PIC/S – USP/EP – Health Canada – US FDA CFR 21 parts 11, 210 & 211 compliance• Batch Releasing• SOPs authoring, review and approval• Quality Management Systems (QMS)• Document Control• GxP training & development• Lean-Six sigma concepts knowledge• Raw materials and finished products analysis• Complaints management• Proficient software use (SAP, MS Office, Outlook, Visio) and troubleshooting skills.
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