Amith Tom — Operations Associate

I am a dedicated Quality Engineer with a rich background, boasting 5 years of expertise in Quality Complaints and Regulatory Compliance within the pharmaceutical industry. During my tenure as a Senior Associate at Steriscience Specialties, I played a pivotal role in cross-functional collaboration, conducting gap analysis, and facilitating organizational change management. My proficiency extends to pharmaceutical compliance regulations, Basic knowledge in Computerized System Validation (21 CFR part 11, GxP, GAMP 5), and comprehensive understanding of quality management processes. Noteworthy achievements include leading initiatives with TrackWise software for streamlined complaint handling deviations Root cause investigation (RCI) & CAPA processes. I have been recognized twice for outstanding performance, showcasing my unwavering commitment to excellence. As a Certified Company Trainer, I have provided training on quality management processes and compliance, contributing to the professional development of my peers. In addition to my professional experience, I hold valuable certifications, including Lean Six Sigma Black Belt, Lean Six Sigma Green Belt( certified by CPD), and Project Management Professional (PMP). Currently pursuing a Data Analytics Certification from the esteemed Indian Institute of Technology (IIT) Roorkee, my coursework encompasses SQL, Python, Machine Learning, Advanced Excel, Power Bi, AI, and statistics. Beyond my technical expertise, I am proficient in English, Hindi, Kannada, Tamil, and Malayalam. My holistic approach to problem-solving, strong analytical skills, and commitment to quality make me a standout candidate in the field and bring a dynamic and forward-thinking perspective to any team or project. Skills: Business Consulting Global Delivery Model Business Process Improvement Cross-Functional Collaboration Sales Pursuits Pharmaceutical Compliance Quality Management Document Management Change Management Risk Management Lean Methodologies

Stackforce AI infers this person is a Quality Engineer with a strong focus on Pharmaceutical Compliance and Quality Management.

Location: Bengaluru, Karnataka, India

Experience: 7 yrs 7 mos