Mohit Kumar Aggarwal

About Mohit Kumar Aggarwal

Ingredient supplier audit, improvement & qualification as per Abbott requirement & …

Experience

1. Manager Supplier Qa, Tpm & Analytical Qa

   Abbott

   Apr 2018 — Present · Mumbai, IN

   Supplier QA: o Supplier auditing, improvement & qualification as per Abbott quality system and based on FSSC & ISO 9001 (Quality systems, HACCP, VACCP, TACCP, PDCA cycle)o Supplier event managemento Suppliers change management o Supplier improvement/development program o Supplier life cycle managemento Anytime audit reediness • Third party manufacturing (TPM) QA:o Supplier site auditing, improvement & qualification as per Abbott quality system and based on FSSC & ISO 9001o TPM startup & operation QA- Validation, Calibration & Verification. HACCP, VACCP, TACCP, PDCA cycle, consumer complain handling.o TPM development, smooth operation and eliminate any potential risk through proactive approach.o Collaboration with TPM manufacturing sites to drive operation excellence, System Validation, QA Compliance, Product transfer, Lab Method Transfer etc. o Stakeholders’ management including identify, monitoring & minimize risk - key coordination with cross functional partners- Regulatory, R&D, GAFS, Medical Safety, ANSC team etc.• Global Projects (Chemical Hazard monitoring & improvement):o Driving Abbott global contaminates surveillance program for mitigation/improvement of chemical hazards risk from supply chain through problem solving tools, process improvements & Controls at different identified supplier sites (DIMAC, FMEA, RCA, CAPA, SIPOC, Funnel analysis, VSM, Brainstorming etc)o Nominated for global key stone award within Abbott Nutritional for significant contribution to organization through chemical contaminant hazard improvement project. • Third Party Laboratory (TPL) QA:o TPL Qualification auditing, improvement & qualification as per Abbott quality system and based on ISO 17025.• Regulatory compliance: o Part of regulatory review board within Abbott Nutritional India network• Software skills: M-file, TrackWise, Abtraq, Minitab, MS Office, Excel, PowerPoint etc

Education

• Uttar Pradesh Technical University

  Bachelor of Technology (B.Tech.)

  2004 — 2008

• Shobhit University, Meerut

  M.Tech Weekend Progm

  2009 — 2011

Skills

• Pharmaceutical Industry
• Sop
• Lc-Ms
• Calibration
• Dissolution
• Technology Transfer
• Glp
• Quality System
• Regulatory Affairs
• Gc-Ms
• Analytical Chemistry
• Pharmaceutics
• Chromatography
• Quality Control
• Gmp
• Hplc
• Validation
• Gas Chromatography
• Analytical Method Validation