Shelly Tomer

Shelly Tomer 📍Mississauga, Ontario, Canada | | ✅PR Holder Professional Summary Results-driven quality and operations professional with 6 years of experience in pharmaceutical manufacturing, quality assurance, and process improvement. Skilled in GxP/GMP compliance, CAPA, root cause analysis, and operational excellence, with a strong record of driving efficiency and regulatory adherence. Experienced in data annotation, AI task support, and digital workflow management, delivering high-quality results with meticulous attention to detail. Adept at collaborating across teams, optimizing processes, and supporting AI/data-driven projects for precision and accuracy. Key Skills Technical / Hard Skills: • GMP, GxP, GDP Compliance • Quality Management Systems (QMS) • CAPA, Deviation & Change Control • Root Cause Analysis & Risk Assessment • Internal & External Audits • Process Improvement / Operational Excellence • 5S, Kaizen, Lean Six Sigma • Data Annotation & Labeling (Image, Audio, Text) • Validation Protocols (URS, FAT, IQ/OQ/PQ) • AI Support / Task Verification Soft / Transferable Skills: • Attention to Detail • Analytical Thinking • Problem Solving • Time Management • Cross-functional Collaboration • Stakeholder Communication • Adaptability • Training & Coaching Professional Experience Akums Drugs and Pharmaceuticals Pvt. Ltd | India Assistant Manager – Quality & Process Improvement | Oct 2024 – Present • Lead cross-functional continuous improvement initiatives, achieving measurable gains in quality compliance, efficiency, and cost savings. • Spearheaded operational excellence (OE) projects, recognized as the highest contributor in 2024. • Directed end-to-end qualification (URS to FAT) of automated equipment including dry syrup filling line, Autocartonator, and capsule filling machines. • Guided teams in root cause analysis, CAPA, and regulatory readiness for audits/inspections. Senior Executive – Quality Operations | Sept 2023 – Aug 2024 • Managed QA documentation, deviation handling, change control, and batch record review. • Supported regulatory audits (USFDA, MHRA, Health Canada) ensuring GMP compliance. • Drove kaizen initiatives, earning 20+ certifications for impactful process improvements. Executive / Apprentice Trainee – Quality Operations | Dec 2019 – Aug 2023 • Conducted in-process checks, line clearance, and controlled batch manufacturing documentation. • Assisted in process validation, qualification protocols, and GMP training initiatives. • Built foundational knowledge in Good Documentation Practices (GDP) and cGMP compliance. Education • Master of Pharmacy (Pharmaceutics) – Uttarakhand Technical University, 2022 – CGPA 8.98 (Honours) • Bachelor of Pharmacy (Pharmaceutical Sciences) – HNB Garhwal Central University, 2019 – CGPA 7.59 Certifications • Lean Six Sigma Yellow Belt (2025) • WHMIS Certified – Alison (2024) • GMP Compliance (WHO-GMP, FDA, ISO) • ISO 9001 & ISO 14001 Familiarity • Top Contributor in Operational Excellence Projects Freelance / AI-Related Competencies • Data annotation & labeling for AI systems (image, text, audio) • Verification & quality review of AI-generated outputs • Analytical evaluation of processes and workflows • Attention to detail for high-accuracy tasks References available upon request